Medical molder boosts quality program with FDA 21 CFR 820


MRPC (Butler, WI), a plastics molder and single-source provider of medical device components and assemblies, has expanded the scope of its ISO 13485 certification to include the requirements of 21 CFR 820, the Food and Drug Administration's quality system regulations for medical devices sold in the U.S.

The company was certified in 2009 to the stringent ISO 13485 standard that requires demonstrating a comprehensive management system for the design and manufacture of medical devices. The FDA 21 CFR 820 standard, though largely aligned with ISO 13485, has guidelines that provide for added requirements in areas such as process control and record keeping.
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