Bringing a life science innovation to market—especially beyond the U.S.—requires more than strong data. It depends on building a solid regulatory and quality foundation early, from documentation and quality management systems to clearly defined indications for use.
In this session, BSI’s Jason Butcher provides a high-level overview of how early-stage companies can align their development and regulatory strategies to support global market access. Topics include the role of quality systems such as ISO 13485 and MDSAP, key considerations for EU MDR and IVDR classification, and how intended use decisions shape regulatory pathways and commercialization strategy.
About the Presenter
Jason Butcher is a seasoned professional in the medical device sector, currently serving as a Senior Technical Specialist and Scheme Manager at BSI. With a strong background in mechanical engineering, Jason brings over a decade of industry experience, particularly in the research, development and manufacturing of orthopedic and soft tissue implantable devices.
Before joining BSI, Jason held roles as an R&D and process engineer where he was instrumental in the design, testing and regulatory preparation of advanced implantable medical devices. His technical expertise and understanding of medical device standards now support his work at BSI where he plays a key role in evaluating high-risk devices and managing certificates schemes under global regulatory frameworks.