FDA’s New Guidance on Cybersecurity for Medical Devices

Russell Haley, Senior Software Engineer at StarFish Medical explains why the new FDA guidance on cybersecurity is important for medical device manufacturers. It changes the way software is going to be developed for new medical devices and what documentation is expected from device manufacturers as part of a submission.
The new FDA guidance on cybersecurity has three main focuses: 1. to ensure that software security is included in all aspects of the software development life cycle 2. ensure that an iterative approach to software security extends into the post-market maintenance and 3. provide better transparency to medical device stakeholders such as hospitals and service providers.
Check out Russell's blog, Overview of the New FDA Guidance on Cybersecurity (starfishmedical.com/blog/fda-...) to learn more about the subject. Follow StarFish on KZbin by hitting the Subscribe button.
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StarFish Medical is an award-winning full-service medical device design company offering design, development, and NPI manufacturing services to medtech startups and global enterprises. We use our Pathfinder process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System and an FDA-registered manufacturing and clean room facility.
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