Join us in person for our Medical Device Roadshow exclusively focused on addressing European medical device regulatory and quality assurance requirements.

Hear from a world-class Notified Body

BSI hosts our 14th annual European Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community.

Join us in person for our Medical Device Roadshow exclusively focused on addressing European medical device regulatory and quality assurance requirements.

BSI will be sharing our current experiences, best practice and expectations from the perspective of the first Notified Body designated under the MDR (EU) 2017/745. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the UKCA scheme.

BSI Regulatory Services consists of a team of over 1000 professionals including technical experts and internal clinicians competent in encompassing the full range of medical devices and management system standards. Our services include system certification to ISO 13485, CE and UKCA certification, product testing, and standardization to support global market access.

Our mission is to ensure patient safety while supporting timely market access to medical technology in a sustainable manner.

Agenda