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Added for You - European Regulatory Language Requirements
Are you currently enrolled in University, but also looking for ways to make extra money? There are many untapped business opportunities available to you, but some are going to be much easier than others. One such money making business that you may consider involves typing the class notes belonging to good students for a small fee, then turning around and selling those well-written notes to students who have missed classes or who are having trouble taking their own notes for another small fee (with the students permission to sell them of course and some commission for them!). You will find that there are many people who will gladly pay you to type their notes because they simply do not have the time to do the organizing themselves. On the other hand, you will also find many students who will gladly pay you a large amount to have their notes written for them, because for some reason or another they simply do not have the note-taking ability that they need.Without well-taken class notes, many students simply cannot do the studying that they need to pass exams, which means that students who have missed classes or lectures or who simply did not take notes will suddenly be in a rush just before an exam to acquire the notes they need for a few quick cram sessions. This is where you come in, because you can sell many copies of the same sets of typed notes to many students all over campus, The most difficult part of making this business work is simply typing the notes, so this business venture may be best for quick typists, or for people who have access to typed notes already.If you are quick at typing, you can gather notes from one or two students from each course, then you can type those notes up and sell them to students in each of the courses. If you do
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe
A command center, sometimes referred to as a war room, can be a competitive differentiator for a business, non-profit or other organization. The key elements for any command center are: centralized location, key personnel, time frames (project, crisis or on-going), mission definition, primary activities and finally, resources as related to organizational commitment. Each on of these points will be outlined below to better portray whether an organization does in fact need a command centerLocation. There are two schools of thought in this area. One is that the command center should be near the hub of action such as the corporate, non-profit or other organizational headquarters. The other is that the command center should be at a remote location and not co-located with the headquarters to keep it safe and to avoid too much executive interference in its workings. If the command center is to serve as an executive “dog and pony” or show facility, then it should be at headquarters. It is then convenience for both executives and for other visiting dignitaries. If the goal is a critical information hub, then the command center can be anywhere. Ideally, not in or even near the headquarters facility.Personnel. The kinds of people who are best for a command center are not necessarily the movers and shakers on their way up in any organization. There are three categories of people who are valuable in the command center environment. The first is the candid veteran leaders or manager. This individual must be fully committed to the center and willing to tell it like it is regardless of the consequences. The second is the expert. There need to be functional experts – the top in their areas – in each of the primary functional areas that the command cent
An exigent regulatory hurdle facing the medical device industry is the European Union's IVDD 98/79/EC directive which went into effect December 7, 2003. Formulated five years ago, the IVDD 98/79/EC dictates that as of the December date, all new in vitro medical devices must bear CE Marks or face refusal into the European market or regulatory, criminal or product/civil liability.
What is the guiding principle behind the new directive?
The IVDD Directive virtually eliminates the costly regulations imposed by individual member states. Manufacturers who comply with the Directive will be able to apply the CE mark to their products and market them freely within member states of the EU. The IVDD (In Vitro Diagnostic Devices Directive) is one of three associated directives issued by the European Union, which together cover all forms of medical equipment with the intent to ensure that only safe and effective products are sold in the European market. The directives clearly outline regulations regarding manufacturing, importing, and marketing of such devices. The IVDD specifically involves in vitro ( in an artificial environment outside the living organism ) medical devices that examine human fluids or tissue samples to identify, diagnose, and monitor medical conditions. The IVDD 98/79/EC brings in vitro devices in line with other medical devices already regulated by the EU, the MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directive).
The IVDD and it sibling directives apply progressive regulatory requirements to medical devices and their accessories depending on the classified risk they present to the user, defined in the directive as Class I through III. Unless the classified product is a low-risk Class I device that does not contain any sterile packaging or a measuring function, manufacturers require a third-party Notified Body to independently certify the device's compliance to the Directive's Essential Requirements (a.k.a. Annex I)-good faith is not enough. Additionally, in a new twist within the Directive, the authorized representative shown on the device label for Class I devices manufactured outside the EU may be required to produce the technical file, including copies of all translated materials. Any incorrect labeling or instructions for use may lead to regulatory criminal or product/civil liability in the EU.
Any medical device manufacturer wishing to market its products in the European Union is fully responsible for complying with the corresponding safety and administrative Essential Requirements and must display the CE mark of conformity as stated in Article 16 of the IVDD 98/79/EC . If that's not a red flag, consider the next regulatory deadline facing in vitro device manufacturers: By December 7, 2005, the European Union will not only require a CE mark to legally market a product, but will require a CE mark to legally put a medical device into service—a requirement much more critical to the revenue of manufacturers and healthcare!
CE Mark: A passport to the European Union
An abbreviation of a French phase "Conformite Europeene," the CE mark indicates that the medical device manufacturer has conformed to all the obligations set forth by the Directive 98/79/EC of the European Parliament. Affixing this multinational standardized mark to a product will allow any global manufacturer a "passport" to freely distribute their products within the European Union without additional quality testing or approvals. Reflective of the 1946 Treaty of Rome, the CE mark is a conformity tool that is intended to further promote the establishment of a single market where the free movement of goods, persons, services and capital are ensured. Fundamentally, the CE mark and the medical device directives remove many regulatory hurdles while providing stronger regulations for smaller countries; however, it also creates critical language compliance issues that may prove to be costly for manufacturers. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.
IVDD, MDD & AIMD…more languages!
Depending on device classification, to legally display the CE mark, the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user's Member State, taking into account the training and knowledge of the potential users as stated in Article 4, Paragraph 4, IVDD 98/79/EC .
Documentation Translation Requirements — Conformity Assessment Procedures Manufacturers are required to translate the documentation relating to the production, testing and quality processes in the official language(s) of the Member State in which the procedures are carried out as stated in Article 9, Paragraph 11 of the IVDD 98/79/EC. Depending on device classification, these documents must include a number of required disclosures dependent on the product classification. Depending on marketing and distribution objectives, some products may require up to 12 languages, creating complicated multilingual product labeling and IFU challenges. There can be over 20 information pieces required for each product label of IFU, depending on the classification as detailed in Annex I, Part B, Section 8 of the Directive.
Table I Official Language(s) of EU Member States
Member State Official language(s)
Austria - German
Belgium - Dutch, French & German
Denmark - Danish
Finland - Finnish
France - French
Germany - German
Greece - Greek
Ireland - English
Italy - Italian
Luxembourg - French, German, Luxembourgish
Netherlands - Dutch
Portugal - Portuguese
Spain - Spanish
Sweden - Swedish
United Kingdom - English
Table II
Official Language(s) of EFTA Member States
Member State Official language(s)
Iceland - Icelandic
Liechtenstein - German
Norway - Norwegian
Switzerland - German, French & Italian
( Switzerland is not a EFTA member but requires translation)
Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)
Bulgaria - Bulgarian
Cyprus - Greek
Czech Republic - Czech
Estonia - Estonian
Hungary - Hungarian
Latvia - Latvian
Lithuania - Lithuanian
Malta - English & Maltese
Poland - Polish
Romania - Romanian
Slovakia - Slovak
Slovenia - Slovenian
Turkey - Turkish
EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe.
Ask iRobot Corp. CEO Colin Angle how his 16-year-old consumer and military robotics business competes with other tech firms to recruit new employees and you’d hear a short, exuberant answer: “We build robots!” To-the-point statements like this back the Massachusetts-based organization’s commitment to engaging employees and customers alike along every step of the development process, from concept to finished product. Eschewing long-winded mission statements, the company builds robots with five simple goals in mind: build cool stuff, deliver great product, make money, have fun, and change the world.Creating an environment that allows employees to reach these goals has helped grow iRobot’s revenue by 58 percent over the last year. (During the same period, the number of employees increased 87 percent.) This astounding performance from a company that, Angle says, failed 18 times before finding success resulted in him being named a FORTUNE Small Business/Winning Workplaces Best Boss in 2005.In less than three years the 300-person firm went from having no HR staff in place to scouring colleges and universities seeking top engineering talent in addition to recruiting experienced professionals. iRobot formally structured its HR component after two of its products took hold en route to changing the world. The company’s Roomba floor vacuum is now a household name, and on the military side its PackBot robots are well known to the U.S. soldiers in Iraq and Afghanistan whose lives they’ve saved.The Roomba was developed based on the suggestion of an iRobot employee. That employee was Paul Sandin. In 1997, with the help of a fellow roboticist, Sandin transformed what was a simple, Lego-constructed robot with rudimentary intelligence into a floor vacuum that
The IVDD and it sibling directives apply progressive regulatory requirements to medical devices and their accessories depending on the classified risk they present to the user, defined in the directive as Class I through III. Unless the classified product is a low-risk Class I device that does not contain any sterile packaging or a measuring function, manufacturers require a third-party Notified Body to independently certify the device's compliance to the Directive's Essential Requirements (a.k.a. Annex I)-good faith is not enough. Additionally, in a new twist within the Directive, the authorized representative shown on the device label for Class I devices manufactured outside the EU may be required to produce the technical file, including copies of all translated materials. Any incorrect labeling or instructions for use may lead to regulatory criminal or product/civil liability in the EU.
Any medical device manufacturer wishing to market its products in the European Union is fully responsible for complying with the corresponding safety and administrative Essential Requirements and must display the CE mark of conformity as stated in Article 16 of the IVDD 98/79/EC . If that's not a red flag, consider the next regulatory deadline facing in vitro device manufacturers: By December 7, 2005, the European Union will not only require a CE mark to legally market a product, but will require a CE mark to legally put a medical device into service—a requirement much more critical to the revenue of manufacturers and healthcare!
CE Mark: A passport to the European Union
An abbreviation of a French phase "Conformite Europeene," the CE mark indicates that the medical device manufacturer has conformed to all the obligations set forth by the Directive 98/79/EC of the European Parliament. Affixing this multinational standardized mark to a product will allow any global manufacturer a "passport" to freely distribute their products within the European Union without additional quality testing or approvals. Reflective of the 1946 Treaty of Rome, the CE mark is a conformity tool that is intended to further promote the establishment of a single market where the free movement of goods, persons, services and capital are ensured. Fundamentally, the CE mark and the medical device directives remove many regulatory hurdles while providing stronger regulations for smaller countries; however, it also creates critical language compliance issues that may prove to be costly for manufacturers. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.
IVDD, MDD & AIMD…more languages!
Depending on device classification, to legally display the CE mark, the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user's Member State, taking into account the training and knowledge of the potential users as stated in Article 4, Paragraph 4, IVDD 98/79/EC .
Documentation Translation Requirements — Conformity Assessment Procedures Manufacturers are required to translate the documentation relating to the production, testing and quality processes in the official language(s) of the Member State in which the procedures are carried out as stated in Article 9, Paragraph 11 of the IVDD 98/79/EC. Depending on device classification, these documents must include a number of required disclosures dependent on the product classification. Depending on marketing and distribution objectives, some products may require up to 12 languages, creating complicated multilingual product labeling and IFU challenges. There can be over 20 information pieces required for each product label of IFU, depending on the classification as detailed in Annex I, Part B, Section 8 of the Directive.
Table I Official Language(s) of EU Member States
Member State Official language(s)
Austria - German
Belgium - Dutch, French & German
Denmark - Danish
Finland - Finnish
France - French
Germany - German
Greece - Greek
Ireland - English
Italy - Italian
Luxembourg - French, German, Luxembourgish
Netherlands - Dutch
Portugal - Portuguese
Spain - Spanish
Sweden - Swedish
United Kingdom - English
Table II
Official Language(s) of EFTA Member States
Member State Official language(s)
Iceland - Icelandic
Liechtenstein - German
Norway - Norwegian
Switzerland - German, French & Italian
( Switzerland is not a EFTA member but requires translation)
Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)
Bulgaria - Bulgarian
Cyprus - Greek
Czech Republic - Czech
Estonia - Estonian
Hungary - Hungarian
Latvia - Latvian
Lithuania - Lithuanian
Malta - English & Maltese
Poland - Polish
Romania - Romanian
Slovakia - Slovak
Slovenia - Slovenian
Turkey - Turkish
EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe
You can hardly visit a trade show, convention or shopping mall in this country without seeing an absolutely amazing modular exhibition stand. The resources and creativity used by the makers of these masterpieces are seemingly endless, allowing their crafts and services to be utilized for purchasing (or renting) one of their designs to promote your own product or business.Conducting research, comparing notes and trial and error were all formerly the best means for choosing the features you’d like to see in your modular exhibition stand. We’ve saved you the burden of this time consuming task, as I have compiled a list of items for you to consider before purchasing this all important addition to your portable advertising portfolio.First and foremost, you will want your modular exhibition stand to be an attention grabber, standing out amongst the masses, just as you want your product or service to stand out within your industry. Originality is crucial to this process, so utilizing an expert design team to create your personalized product is, without a doubt, worth the investment. If you are renting an exhibition stand, the assistance of a professional to help you make the most of your arrangement will definitely yield positive results.Another feature that falls closely in importance is the maneuverability of the components and its ease of transportation. The use of magnets and/or fabric is just a few of the options available to ease this sometimes tricky situation, especially if your cargo area is limited, for these materials will help to utilize your restricted space more effectively. Plus, lightweight fabrics and other materials are much easier to tote around from one location to another, whether you are moving it personally, or paying to h
IVDD, MDD & AIMD…more languages!
Depending on device classification, to legally display the CE mark, the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user's Member State, taking into account the training and knowledge of the potential users as stated in Article 4, Paragraph 4, IVDD 98/79/EC .
Documentation Translation Requirements — Conformity Assessment Procedures Manufacturers are required to translate the documentation relating to the production, testing and quality processes in the official language(s) of the Member State in which the procedures are carried out as stated in Article 9, Paragraph 11 of the IVDD 98/79/EC. Depending on device classification, these documents must include a number of required disclosures dependent on the product classification. Depending on marketing and distribution objectives, some products may require up to 12 languages, creating complicated multilingual product labeling and IFU challenges. There can be over 20 information pieces required for each product label of IFU, depending on the classification as detailed in Annex I, Part B, Section 8 of the Directive.
Table I Official Language(s) of EU Member States
Member State Official language(s)
Austria - German
Belgium - Dutch, French & German
Denmark - Danish
Finland - Finnish
France - French
Germany - German
Greece - Greek
Ireland - English
Italy - Italian
Luxembourg - French, German, Luxembourgish
Netherlands - Dutch
Portugal - Portuguese
Spain - Spanish
Sweden - Swedish
United Kingdom - English
Table II
Official Language(s) of EFTA Member States
Member State Official language(s)
Iceland - Icelandic
Liechtenstein - German
Norway - Norwegian
Switzerland - German, French & Italian
( Switzerland is not a EFTA member but requires translation)
Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)
Bulgaria - Bulgarian
Cyprus - Greek
Czech Republic - Czech
Estonia - Estonian
Hungary - Hungarian
Latvia - Latvian
Lithuania - Lithuanian
Malta - English & Maltese
Poland - Polish
Romania - Romanian
Slovakia - Slovak
Slovenia - Slovenian
Turkey - Turkish
EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe
You've started a business and built a website, and you thought the hard part was over. Guess again. Now it's time to let the world know your business exists.Starting a business or putting up a website won't bring the world to your door. You will have to do that with some strategically planned marketing. You can have the best product or service that money can buy, but nobody will be buying if they have never heard of you.Here are some simple, inexpensive ways you can use to get the word out about your business and your website. These steps include both online and offline marketing, because the more diverse you are in your strategy the more likely it is to work for you.1) Create a signature for your email. At the very least, this should include your name, business name, a tagline if you have one, your website address and your email address. You may also wish to include a phone number and postal address. In general, a signature shouldn't exceed six lines.2) Create a signature for every forum to which you belong. Just as you will have a signature for your email, you'll also need one for any forums you visit. Forums are a great way to get the word out about your business because it lets others meet you before they buy from you. This boosts their confidence in you because they have already benefited from your expertise on the forum, and when they are ready to visit your website or contact you, they'll have your information right there in your signature.3) Create a profile for the public to see on websites such as Myspace, Amazon and Ebay. Your profile on websites such as these can tell others about your business and mo
Table I Official Language(s) of EU Member States
Member State Official language(s)
Austria - German
Belgium - Dutch, French & German
Denmark - Danish
Finland - Finnish
France - French
Germany - German
Greece - Greek
Ireland - English
Italy - Italian
Luxembourg - French, German, Luxembourgish
Netherlands - Dutch
Portugal - Portuguese
Spain - Spanish
Sweden - Swedish
United Kingdom - English
Table II
Official Language(s) of EFTA Member States
Member State Official language(s)
Iceland - Icelandic
Liechtenstein - German
Norway - Norwegian
Switzerland - German, French & Italian
( Switzerland is not a EFTA member but requires translation)
Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)
Bulgaria - Bulgarian
Cyprus - Greek
Czech Republic - Czech
Estonia - Estonian
Hungary - Hungarian
Latvia - Latvian
Lithuania - Lithuanian
Malta - English & Maltese
Poland - Polish
Romania - Romanian
Slovakia - Slovak
Slovenia - Slovenian
Turkey - Turkish
EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe
One of the prime features of high-quality barcode labels is durability. Durable barcode labels are vital for any industrial application and are integral for equipment marking and security. These are important for cassettes, plates, slides, vials, and laboratory and medical items.Durable barcode labels can withstand abrasion, corrosion, moisture, heat, solvents, and UV light. Accuracy, clarity, consistency, easy identification, flexibility, high quality, legibility retention, and reliability are the major advantages of durable barcode labels. Warehouse barcode labels, work-in-process barcode labels, utility asset labels, barcode labels for industrial use, asset tags for property identification, and polyester barcode labels are some examples of durable barcode labels.Durable barcode labels are available in a range of adhesive backings and are generally categorized into aluminum barcode labels, polyester barcode labels, and ceramic barcode labels. Aluminum barcode labels are able to resist wear and tear and harsh chemicals. Polyester barcode labels have permanent industrial adhesive bonding, which ensures dependability. Ceramic barcode labels are coated with ceramics and have a stainless steel base. This type of label can withstand extreme temperature and strong acids. Durable barcode labels are also made from materials like polypropylene, polycarbonate, photo anodized aluminum, and stainless steel.Quality of label stock, ribbon, printing technology, and barcode label programs employed are the primary factors, among many others, that determine the durability of barcode labels. Since they have the capability of printing long-lasting images on a range of materials, thermal-transfer printers are generally used to produce scratch-resistant, durable
As the EU continues to grow and the trading barriers dissolve, prospective Member States are actively transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.
In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slovakia, and Turkey, see
TABLE III .
Global Harmonization and International Quality Standards
In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulations. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe.
ISO (International Organization for Standardization) Adding to the pressure the current ISO 9000:1994 standard is transitioning to a new ISO: 9000:2000 series effective December 14th of this year. However, as of May 15, 2003, only 19.5% of the total ISO registered North American companies had completed their registration process. This is essential in the entire chain of requirements. The new standard is a consolidation of ISO 9001 and 9002, and has more of a customer satisfaction and continuous improvement focus not present in previous versions.
GMP (Good Manufacturing Practices)
In December 1978, the FDA Good Manufacturing Practices (GMP) Regulation became effective, establishing Quality System Requirements for products regulated under the FDA, including medical devices. In 1990, the Safe Medical Devices Act (SMDA) expanded the GMP to include design, manufacturing, packaging, labeling, storage, installation and servicing of all finished medical devices.
Exporting American Medical Devices
Any medical device in the US market may not be legally exported anywhere in the world without prior FDA notification or approval; however, for a device to be legally distributed in the US, the FDA requires:
Registration of both the medical device and manufacturing site
- Authorization for commercial distribution through either a 510(k) pre-market notification or a Pre-market Approval (PMA) application depending upon the classification of the device
- Compliance with FDA labeling requirements
- Manufacturing compliance with the FDA's Good
Manufacturing Practices (GMP)
While the FDA does not place any restrictions on the export of these devices, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations. Medical devices that do not have a 510(k), PMA, or are solely manufactured for export may by approved for exportation by the FDA through Section 801(e)(1) of the FFDCA; however, the manufacturer may experience regulatory difficulties depending on the individual country's requirements of an FDA Export Certificate, which, as stated above, require a 510 (k) or a PMA.
Sorting through the regulations to achieve global product delivery The question facing medical device manufacturers in the current global market is how to meet all language requirements in the most cost-effective, regulatory compliant manner. Managing regulations and translations are among the most critical aspects of developing and marketing products for the life sciences industries. Any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. Therefore, developing translation and localization processes has become a competitive advantage for global manufacturers of medical devices.
Working closely with a translation and localization vendor who specializes in medical language services is an important step in conquering the ever-changing international regulatory process. The choice of the translation provider is extremely important to ensure that translations are accurate, consistent and technically correct, as well as harmonious with the manufacturers' processes.
Medical language service providers should—at the very least—provide documented processes that involve native-speaking linguists that have expertise in both medical translation and the medical industry. To deliver consistency, quality and reduced costs, the language service provider should also implement terminology management tools and computer-assisted translation solutions in concert with the team of human translators.
Conclusion
Complex and ever-changing international regulations controlling the marketing and usage of medical devices are forcing manufacturers to incorporate language translation and localization into global development strategies. The European Union members currently require that all product information be in the official language of the local users and the diversity of this economic area is only growing to include more regulations and official languages. A simultaneous global release of medical devices involving up to 12 languages in Europe alone makes this issue as critical as the intended purpose of the medical device.
Medical device manufacturers can cost-effectively market their products globally while satisfying international regulatory requirements by partnering with Net-Translators a qualified language service provider in the very early stages of product development. The right language partner can turn what may now appear as a chaos of regulatory requirements into a successful international product release.
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