Navigating FDA 60601-1 Compliance for Medical Devices
July 16, 2019
For years the US Food and Drug Administration has mandated that medical devices comply with 60601 standards for near-patient safety, and while that’s great for patients, it can be a difficult or frustrating road to navigate for medical device manufacturers. 60601-1 ratings are given to devices…
For Medical Device Manufacturers, Compliance Can Hinge on your Technology Partner
October 12, 2017
There are constant revisions to compliance in the medical field; Wikipedia cites that the FDA recently released several regulations to medical devices and how they handle sensitive patient data. Cleanliness, compatibility, safety, and cyber-security standards are ever-changing. It can be maddening…
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