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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.

"For today's medical device firms, finding a manufacturing partner with industry-leading quality systems in place is a top priority," said Michael Dalton, MRPC's director of quality. "Our commitment to meeting the industry's most demanding regulations, as well as our experience in the medical market, makes MRPC a reliable choice for their molding needs."

For more information on MRPC, click here

MRPC, which specializes in silicone, two-material molding, and micromolding, chose to pursue the certification after recognizing that many of the companies it works with want their supplier partners to meet the same stringent regulatory standards they do. The FDA's 21 CFR 820 guidelines are designed to protect the safety and effectiveness of finished medical devices by regulating their "design, manufacture, packaging, labeling, storage, installation, and servicing."

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