Pantheon Quality Systems (PQS)

Our company exists to help Medical Device OEMs and contract manufacturers develop compliant and lean QMS in the fastest and most efficient way to facilitate the manufacture of components/finished safe products and bring them into market despite myriad regulations and other hurdles, and thus help patients. Why Get ISO 13485 Certified? The first question when an OEM courts a medical device component manufacturer is typically: “Are you ISO 13485 certified?” The answer carries a lot of weight. Besides the revenue incentive from additional business from OEMs, ISO 13485 certification instantly gives a medical device component manufacturer credibility, gets you recognized as more reputable and trustworthy providers. Because the medical device and equipment industry is highly regulated, OEMs need assurance that their new products will be in full regulatory compliance once their products hit the market. In fact, the recent ISO 13485:2016 revisions have helped align medical device quality requirements with U.S. FDA requirements. Working with an ISO 13485 certified manufacturer gives medical OEMs greater assurance that their products will pass the rigorous quality and safety requirements specified in FDA regulations. ISO 13485 also helps avoid Litigation and Liability with a Registered Contract Manufacturer. Litigation and liability within manufacturing industry, and specifically within medical device field, has grown to a previously inconceivable level over the last decade. “It’s a jungle out there” doesn’t begin to cover the hazards of today’s true business environment. For the experienced and successful businesses, due diligence has ceased to be something that is “done” and has instead become as second nature as taking a breath.