NSAI Offers European and Canadian Certifications Within 60 to 90 Days

A U.S. subsidiary of the notifying body National Standards Authority of Ireland (NSAI) is refocusing its certification efforts by offering device manufacturers a way to obtain European Union (EU) approval or Canadian Medical Devices Conformity Assessment System (CMDCAS) certification within 60 to 90 days, Chris Morrell, vice president of NSAI’s U.S. division, said.

Morrell explained that it often takes device manufacturers 90 to 120 days just to get on a schedule for certification, and it could take months to years for a firm to obtain a CE mark, necessary for marketing a device in the EU, or CMDCAS certifications.

NSAI’s new certification process for medical devices applies to CE marks, CMDCAS certifications and global ISO 13485 certifications, Morrell said.