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Medical Device Software Development Management:Following FDA Guidelines for Software Validation
Developing software for medical devices that complies with the FDA's Quality System regulation is a
challenging endeavor that's as much a business issue as it is an engineering feat.
Read this white paper to discover:
- Software development challenges that medical device makers face
- Why the FDA recommends a software development lifecycle (SDLC) approach that integrates risk management strategies with principles for software validation
- And tips for putting the FDA's recommended approach into action.