Software Development for Medical Device Manufacturers - Canceled!


This course has been canceled and will be rescheduled in the fall.

This course will be presented with a live instructor using web-meeting software. The course content will be covered in 4 sessions presented over four days.

COURSE SUMMARY:  Developing software in compliance with the FDA Design Control regulation, changing FDA guidance documents and latest international standards is challenging. This intensive course provides practical solutions and suggestions for developing software in a manner that meets applicable FDA regulations, guidance documents and international standards, such as IEC-62304:2015. The focus is on interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the perspective of software development. Discussions on key topics such as Software Requirements, Traceability, Design Reviews, Software Verification & Validation and Risk Management (including recently updated standards ISO-14971:2019 and EN-14971:2019) are included. Also discussed are FDA requirements for validation of software development tools and software used in Manufacturing and Quality Systems. Also discussed are recent FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability.

THIS COURSE IS INTENDED FOR…Software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who needs to develop cost-effective processes 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. 

COURSE OUTLINE:  This course will be presented with a live instructor using web-meeting software. The course content will be covered in 4 sessions

  Date and Time




  • Start time: 03 May 2021 01:00 PM
  • End time: 06 May 2021 04:00 PM
  • All times are US/Eastern
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  • Boston
  • United States

  • Starts 24 November 2020 01:00 PM
  • Ends 28 April 2021 01:00 AM
  • All times are US/Eastern
  • Admission fee ?


Steve R. Rakitin


Software Development for Medical Device Manufacturers


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.