The addition of software in 21st century medical devices has added yet another level of regulatory, quality and design challenges for medical device manufacturers, healthcare professionals and patients. Standards and guidance documents are being written to help industry and regulators address the complexity of regulating and ensuring safety in this constantly evolving technological field. These challenges include incorporating Agile practices and life cycle processes in software development, cybersecurity concerns, differences between SiMD and SaMD and evolving regulatory requirements.
Come join RAPS Twin Cities chapter and your fellow regulatory professionals to learn more about these software changes and challenges. This presentation will provide updates on software standards (IEC 62304, AAMI TIR45), networked medical devices (IEC 80001-x), Cybersecurity Software Bill of Materials (SBOM) and the FDA pre-Cert Pilot Project for SaMD.
This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate professional development and networking opportunities for regulatory professionals in your region. A meal will be provided for all attendees and RAC holders may claim two RAC recertification credits.
Patty Krantz-Zuppan, standards manager, distinguished engineer and technical fellow, cardiac rhythm and heart failure, Medtronic