RAPS Twin Cities Chapter: Use and Expectation for Harmonized Standards in Medical Devices

Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on harmonized standards in medical devices. This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. A meal will be provided. RAC holders may claim 1.5 RAC recertification credits.

Compliance with harmonized standards provides a presumption of conformity with the corresponding requirements of harmonization legislation. Medical device manufacturers and assessment bodies can use harmonized standards to demonstrate that their products, services or processes comply with relevant EU legislation.

This presentation will describe CEN and ISO standards, the significant differences between them and how they are developed. It will also provide an overview of the relationship of standards to medical device legislation in the EU and the United States, and how best practice application of standards can be used to show presumption of conformity to legal requirements in all phases of the product lifecycle.