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Life Sciences
5 items tagged with "life-sciences"
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Regulations4
Regulation
FDA 21 CFR Part 11 Electronic Records and Signatures
US FDA regulation setting requirements for trustworthy electronic records and electronic signatures in regulated life-sciences systems.
Regulation
EU Medical Device Regulation (Regulation (EU) 2017/745)
EU regulation governing the safety, performance, and market access of medical devices, including software as a medical device.
Regulation
EU In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746)
EU regulation governing in-vitro diagnostic medical devices and related software, raising risk classification and clinical evidence requirements.
Regulation
FDA Premarket Cybersecurity Requirements for Medical Devices (Section 524B)
U.S. FDA requirements obliging makers of connected medical devices to address cybersecurity in premarket submissions, including SBOMs and update plans.