CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation

2020-08-11T09:12:12+00:00July 7th, 2020|

What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of [...]

Surface finish and biocompatible materials for pharmaceuticals and medical devices

2020-08-30T12:53:28+00:00June 18th, 2020|

Medical device surface treatment Surface roughness level is a parameter of surface quality, commonly measured as the average deviation of the surface profile from the mean line (Ra). [...]

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