Software Development for Medical Device Manufacturers
PREPARE FOR THE NEW FDA QMSR + ISO 13485 COMPLIANCE REQUIRED FEBRUARY 2026
Developing software in compliance with the FDA Design Control regulation, changing FDA guidance documents and latest international standards is challenging and the regulatory landscape for medical device software development is changing dramatically. Beginning in February 2026, device manufacturers must comply with the new FDA Quality Management System Regulation (QMSR) which is based on the ISO 13485 Medical Device Quality Management System Standard. In addition, a recently adopted standard for security risk management (AAMI SW96) adds additional requirements for cybersecurity. This course provides insight into these changes as well as requirements for safety risk management as defined in ISO 14971 Medical Device Risk Management and IEC 62304 Medical Device Software – Software Life Cycle Process. Also discussed is IEC 62366-1 Medical Devices – Application of Usability Engineering.
Instructor
Steve Rakitin
Steven R. Rakitin has over 45 years experience as a software engineer. He has over 30 years of experience in the medical device industry and has been a medical device consultant for over 20 years. He has worked with over 100 medical device manufacturers and biotech companies worldwide, from startups to Fortune 100 corporations. He has published papers on medical device software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers. He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Senior Life member of IEEE. Steve works collaboratively with medical device companies to help them comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.
Who Should Attend: Software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who is interested in learning about cost-effective processes and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with FDA/EU regulations and international standards. This course is also appropriate for people who are new to the medical device industry. Extensive reference documents are available by requesting a DropBox link. and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with FDA regulations and international standards. This course is also appropriate for people who are new to the medical device industry. Course notes, access to an extensive collection of reference documents and a training certificate are provided.
Publication Year: 2026