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Medical Device & IVD Usability Testing and FDA Human Factors Requirements

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FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Certification Need to Know

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Evaluating and Accepting Medical Device and IVD Residual Risk

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ISO 14971 Certification Plus 5 More Medical Device Risk Management Myths

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Overview of Medical Device Cybersecurity Standards and Guidance Documents