Medical Management Systems Auditing and Certification
Your medical device is state-of-the-art - faster, stronger, and better than the competition. Don't settle for less when it comes to your management systems certification.
Most countries require you to have a third-party audited and certified management system in place before selling any medical product. However even with a certificate on the wall, are you really assured that your system is robust enough to meet the demands and constant changes of the fast-paced medical industry? You will be if it is an Intertek certificate.
Unlike many other registrars, Intertek is a true "one-stop shop" of auditing, inspection, testing, quality assurance, and certification services for the medical industry. Our unique combination of in-depth expertise has brought confidence and assurance to thousands of organizations all over the world. With our wide range of auditing services, you can easily satisfy all your markets' requirements in a single audit:
- Quality management systems certification to ISO 13485:2003, including CMDCAS for Canadian market approval, Health Canada/TGA MOU for access to Australia, and the Technical Cooperation Program (TCP) for accelerated access to Taiwan
- Risk management systems certification to ISO 14971:2007
- Medical Device Directive (MDD) conformity assessment services for CE marking
- FDA Accredited Persons (AP) Inspection
- Quality system (GMP) assessments for Japan's Pharmaceutical Affairs Law (PAL)
- QMS assessments to the Dental Appliance Manufacturers Audit Scheme (DAMAS)
With a high level of technical expertise and an unparalleled focus on customer satisfaction, we help you manage the regulatory process so you can focus on delivering a better product.
Request more information to see how Intertek can help your organization with Medical Management Systems Auditing and Certification.