BSI Unveils "Passport to Europe" Program

Press release - Reston, VA - January 26, 2010

BSI, a world-class 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 complementary educational webinars for emerging, new and small medical device manufacturers interested in selling their products in Europe.

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 for companies looking to break into Europe to 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:

• Getting Started with CE Marking for Medical Devices—February 4, 2010
• Getting Started with ISO 13485 Quality Management—February 18, 2010
• Clinical Evaluation 101 for Medical Devices—March 18, 2010
• Introduction to Risk Management for Medical Devices—April 8, 2010

“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 U.S.,” said Paul Brooks, Vice President, BSI Healthcare.  “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.”