Medical Device Regulations Software In Europe
2 software items found
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Manufactured by Covartimbased in BELGIUM
A standalone software, such as a mobile or web application, can fall within the definition of a (IVD) medical device. Therefore, the placing on the market is well regulated and specific actions need to be ...
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based in USA
OOS Software to Automate Out of Specification (OOS) Processes to Comply with FDA CGMPs and 21 CFR Part 211 and Part 820 Regulations. In the FDA environment, specifications are essential in maintaining quality. CGMP regulations for finished pharmaceuticals (21 CFR Parts 210-211) and medical devices (21 CFR Part 820) require strict ...
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