Author: Kris Kelly

medical device quality

Top 5 Reasons Medical Device Projects Succeed

Medical Device Projects Can Be Successful During COVID-19 1) Make Sure User Needs are Complete and Stakeholder Approved All successful projects begin with the user in mind Involved stakeholders keep everyone focused on the...

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Would your Non-Product Software PASS an FDA Audit?

Are you at Risk of Non-Compliance…for Non-Product Software Tool Validation? How do you know if you’re fully compliant? What we’ve observed. Because we provide QMS Support to Biotech, Pharma & Medical Device companies, we’ve...

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