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MRPC completes ISO 13485:2016 recertification process

MRPC, a fully integrated contract manufacturer of medical device assemblies and components, recently completed the ISO 13485:2016 recertification process, extending its accreditation through Sept. 3, 2027. The ISO certification includes all three of its medical manufacturing facilities.

ISO 13485 is an international standard outlining the requirements for Quality Management Systems in the medical device industry and covers the entire life cycle of a device, from design to development, production, installation, and servicing.

“Holding the ISO 13485:2016 certification signifies to our current and prospective customers that we have a Quality Management System in place, and highlights that we have procedures in place for the quoting process, product development, production, shipping, quality, and other processes,” says Eric Powers, VP of Quality Assurance. “But ISO is more than a quality system, it’s a full business system that has essentially become a prerequisite for medical device manufacturers.”

MRPC implemented corporate-wide standardization of Quality Management Systems several years ago. All three locations follow a standard quality manual, departmental procedures, and corporate work instructions. This standardization enables the company to reduce waste and create alignment on company objectives and customer programs.

MRPC gained ISO 13485 certification in 2009 and has held the certification for the past 15 years. In addition, MRPC is MedAccred Injection Molding accredited, offers FDA Registration (as a contract manufacturer), has NSA compliance capabilities, and is NSF certified.