JassySam's articles

The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.   The healthcare and wellness industry […]
The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard.  FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities […]


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