(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.

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