Expert Insights | Documents

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
Team NB Position Paper Submission of Technical Documentation Highlights
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Team NB Position Paper Submission of Technical Documentation Highlights

March 16, 2023 5 min read
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
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Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions

January 18, 2023 5 min read
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
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Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

January 13, 2023 4 min read
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
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European Union Clinical Trials Regulation: Mandatory Deadline Approaching

December 20, 2022 3 min read

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