Join us May 12 in person or online via Zoom for a Life Science Venture Program education session on International Markets — Regulatory Considerations for Life Science Ventures. The session will be led by Jason Butcher, Senior Technical Specialist and Scheme Manager, Vascular Devices at BSI.
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, experts from BSI will provide a high-level overview of how early-stage companies can align their development and regulatory strategies to support global market access. Topics will 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.
Designed for founders and emerging life science ventures, this session will highlight practical considerations for avoiding common pitfalls and building a regulatory approach that supports long-term growth and successful market entry.
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.
In person attendees are invited to join us for a Beer & Biotech networking reception afterward from 5-7 PM at RP Tracks. Learn more about the Beer & Biotech and register here.
