SMEs in the MedTech sector

Globally, more than 85% of manufacturers we work with across all regulatory certification services are SMEs. We continue to accept new applications and as we do so, we are always learning. We will continue to refine our supporting tools and to increase the number of SMEs we work with.

BSI fully understands the difficulties that may be encountered throughout the process to place a medical device on the market, from application to conformity assessment, certification and post-market surveillance. We offer a wide range of resources dedicated to increase your knowledge on key regulatory topics and steps needed to support your market readiness.

Access BSI medical devices webinars portfolio! You can navigate on demand and register for upcoming free live webinars and masterclasses led by our Technical Specialists and Regulatory and Clinical experts. You can choose from an extensive directory on regulations, standards, market access and more.

Want to deepen your knowledge even more? BSI medical devices offers a comprehensive training portfolio delivered by industry experts from all around the world! Our highly specialized courses provide an in-depth understanding on key topics regulating medical devices, IVDs and Quality Management System, to increase your knowledge on compliance, implementation and maintenance of regulatory requirements.

A unique digital, multi-user platform designed to monitor your compliance against over 6,000 essential documents regulating medical devices, IVDs, QMS and other key topics. Create regulatory profiles and templates, profit of smart support and external expert commentary, receive alerts on changing standards and much more!

BSI offers a comprehensive directory of free whitepapers focused on regulations, standards, clinical investigation and evaluation, surveillance processes and much more. Access our subject matter experts’ whitepapers and discover the best practices for the most requested key topics in the medical device sector.