US FDA proposals on risk-based clinical trial monitoring and their implications for medical device manufacturers
This article was originally published in SRA
Executive Summary
Nancy J Stark discusses the Food and Drug Administration's draft guidance on overseeing clinical investigations and considers the pros and cons of the proposals for device manufacturers.
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Key revisions to medical device clinical investigations standard ISO 14155
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Key revisions to medical device clinical investigations standard ISO 14155
Nancy J Stark compares the new and old versions of ISO 14155 and explains why manufacturers operating in Europe will bear the brunt of the changes.