Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA guidance documents related to software and international standards including IEC 62304 and ISO 14971. The focus of this course is interpreting the FDA QSR regulation and guidance documents for software. Each section of the FDA Design Controls regulation (820.30) is discussed from the software perspective along with corresponding requirements from IEC 62304.
In-depth discussion of critical topics such as Requirements, Software Verification & Validation, and Risk Management are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

Who Should Attend?

Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.

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Pamela Bump

Pamela Bump is a candidate for the Master of Science in Media Ventures at Boston University. After receiving a B.A. for a dual major in Journalism and Communication Studies from Keene State College in 2014, she became the Web Editor and Social Media Expert at Taste for Life Magazine, an alternative health publication. She then served as Copy Editor at The Keene Sentinel, a daily newspaper in Keene, N.H. While editing daily city news and designing pages for print, she also managed, edited, and contributed to a weekly health section.

As a Media Ventures student with a passion for health journalism, Pamela hopes to use her time at MedTech to expand storytelling skills, while learning about leadership and innovation in the media-startup industry.

Latest posts by Pamela Bump (see all)

• Resources and Information for the Boston Area - September 7, 2017
• This Year’s Disruptive Dozen at the World Medical Innovation Forum - May 9, 2017
• PARTNERS CONNECTED HEALTH LAUNCHES 2017 CONNECTED HEALTH INNOVATION CHALLENGE - May 8, 2017