U.S. Bill to Modernize FDA Device Inspections

A bill was introduced in the U.S senate to to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. A bill is essentialy a draft law and may or may not become law and may or may not be significantly modifed in the process of approval. The full bill is at the link provided.

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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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