Software Development for Medical Device Manufacturers

An intensive two-day course…

Developing software in compliance with the FDA Design Control regulation, changing FDA guidance documents and latest international standards is challenging. This two-day 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. The focus of this course 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 EN-14971:2012), are included. Also discussed are FDA expectations for validation of software development tools and software used in Manufacturing and Quality Systems.Recently issued FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability are discussed. Interactive group exercises are included to facilitate discussion and learning.

Who should attend…

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. Each attendee receives course notes, access to an extensive collection of reference documents and a training certificate.

About the instructor…

Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He helped write the first IEEE Software Engineering Standard (IEEE-STD-730 Standard for Software Quality Assurance Plans) and worked on revisions to both IEEE Standard 1012-2012 (Software Verification & Validation) and IEEE 730-2014 (Software Quality Assurance). He has written several papers on software quality 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 the IEEE and is a member of MassMEDIC. As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.

Feel free to contact me at steven.rakitin@gmail.com if you need additional information about the course. Click here to register for the course on-line or call IEEE Boston at 781.245.5405.