BUTLER, Wis. (Dec. 15, 2010) – MRPC, a leading single-source provider of medical device components and assemblies, has broadened 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.
MRPC received the stringent ISO 13485 certification in 2009, demonstrating a comprehensive management system for the design and manufacture of medical devices. While largely aligned with ISO 13485, the FDA 21 CFR 820 guidelines provide additional requirements in certain areas, including process control and recordkeeping.
“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.”
The FDA’s 21 CFR 820 guidelines are intended to protect the safety and effectiveness of finished medical devices by regulating their “design, manufacture, packaging, labeling storage, installation and servicing.”
MRPC, which specializes in silicone, two-material and micro-molding, decided to pursue the certification after recognizing that many of the companies it works with want their partners to meet the same stringent regulatory standards they do.
MRPC, a single-source provider of innovative medical device components and assemblies, specializes in clean room molding with a focus on silicone molding, two-material molding and micromolding. MRPC is committed to providing its customers with the highest level of expertise. Since 1921, MRPC has been helping customers compete in an ever-changing marketplace. MRPC is ISO 9001- and ISO 13485-certified and FDA 21 CFR 820-compliant. For more information, please visit the company’s Web site at http://www.mrpcorp.com or contact the company at 262-781-7122.