Posts Tagged ‘FDA Compliance’

  • IEC 62304 – The Basics

    on Sep 9, 10 • by Brendan Harrison • with 2 Comments

    MRI Software

    IEC 62304 is becoming a hot topic amongst medical device software professionals. We asked Bruce Swope, VP Engineering at SterlingTech Software for his views on this standard and what it all means for medical device companies. Bruce has extensive experience in medical device software development and he is an expert in leading Class III medical software products to commercial release. His depth of experience also spans the development of enterprise solutions, security applications, internal applications, and process control systems. He has been an early adopter of quality practices including ISO 9000 processes, Common Criteria Certification

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