Cork Medical is pleased to announce that its manufacturing facility's Quality Management System was registered and certified by Intertek, a Medical Device Single Audit Program (MDSAP). The certification ensures Cork Medical conforms to the requirements of ISO 13485:2016 for medical device manufacturing for the U.S. and Canada.
“Intertek’s registration and certification of Cork Medical moves us up another level as a top manufacturer in the world and also opens new opportunities in major markets like Europe and Canada," said Vice President of Distribution Josh Boller. "We’re proud of this accomplishment and look forward to improving lives with the NISUS NPWT Device in more countries.”
The registration certifies that a Quality Management System is in place, is effective, and meets the requirements for the standards set by ISO for quality assurance in the production of safe and effective medical devices. The certificate applies to Cork’s Management System for design, development, manufacture, distribution, and service of negative pressure wound therapy pump and single use accessories; as well as patient mattresses and cushions.
”The manufacturing team and the management team has put in a tremendous effort to make this a reality," said Engineering Manager Brian Dean. "The certification is a major accomplishment that will take Cork Medical to new heights and new markets.”
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