MRPC Awarded ISO 13485 Certification

MRPC has received ISO 13485 certification. The certification covers all disciplines within the company. MRPC is also ISO 9001 certified.

The certificate confirms that MRPC has successfully implemented a quality management system that matches the worldwide quality management system standard for medical devices. It demonstrates MRPC’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

“We pursued ISO 13485 certification because ensuring delivery of the safest and most effective products possible better serves our customers, “ says Michael Dalton, director of quality at MRPC. “Producing high-quality components and assemblies keeps customers coming back and opens up new medical device markets for us in more sophisticated areas, including implantables.”

MRPC’s sophisticated training and quality improvement programs, together with its experience, made seeking the ISO 13485 certification a logical next step. In addition, MRPC is finding that, more and more, the medical device companies it works with want their partners to meet the same high regulatory standards that they do.

“While the ISO 13485 certification is still in its infancy, we think that it will become a standard requirement of medical device manufactures within three to five years,” Dalton says. “MRPC wanted to jump ahead of the curve to demonstrate that we offer our customers the best and most efficient services today.”

ISO 13485 is an International Organization for Standardization (IS0) standard that focuses on the unique and rigorous requirements for companies involved in the development of medical devices. Manufacturers must demonstrate that quality management systems are implemented and maintained to receive the certification, which addresses such quality issues as risk management, sterilization and traceability.

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