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FDA Compliance

BSI Unveils “Passport to Europe” Program

Program educates medical device manufacturers on CE marking regulatory process and breaking into European market.

Published: Friday, January 29, 2010 - 12:47

(BSI: Reston, VA) -- BSI, a notified body providing regulatory and quality management reviews for medical devices, kicks off its “Passport to Europe” program. As part of the program, BSI will be conducting a series of complimentary educational webinars for emerging, new, and small medical device manufacturers interested in selling their products in Europe.

“We are looking to grow the BSI "Passport to Europe" program to include additional services based on the needs of manufacturers and to help demystify the process so they can get started on the road to the European market,” says Paul Brooks, vice president of BSI’s health care and medical devices sector.

Obtaining CE marking gives medical device manufacturers access to the 27 countries with nearly 500 million people that make up the European Union (EU), opening up a wealth of revenue and business development opportunities. The regulatory process, however, can be complex and time consuming—making it critical that companies looking to break into the EU market clearly understand the process, potential challenges, and best practices for ensuring product safety and speed to market.

The BSI "Passport to Europe" program is primarily designed for manufacturers; however, it is available to consultants, venture capitalists, marketing professionals, or anyone interested in learning more about the medical device regulations that govern placing products into the EU.

This new program leads off with four complimentary one-hour webinars. Participants will come away with a basic understanding of the European regulatory process, covering topics from the impact the Medical Device Directive (MDD) requirements have on marketing a new medical device in the EU, to quality and risk management systems. Specific sessions will include:


“Access to the EU marketplace provides companies with tremendous growth opportunities and many companies—especially emerging or small manufacturers—may find it makes the most business sense to initiate the EU process concurrently or even prior to obtaining FDA clearance in the United States,” says Brooks.

To register for the Passport to Europe series, please visit www.bsiamerica.com.


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BSI (British Standards Institution) works with more than 80,000 clients in 172 countries to help them adopt and cultivate the habits of excellence. Clients are trained and provided with practical guidance for implementation alongside a suite of compliance tools. BSI is assessed and accredited by more than 26 accreditation bodies including ANSI-ASQ National Accreditation Board (ANAB) and United Kingdom Accreditation Service (UKAS). BSI’s influence plays a key role within the International Organization for Standardization (ISO). As one of the founding members, it ensures that international standards address business and societal needs, while delivering real benefits to organizations.