MDD Compliance Using Quality Management Techniques

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For example, in order for a medical device to be sold in Canada, the Health Canada Canadian Medical Device Regulations Program requires that manufactures provide evidence that their medical devices are produced under a quality system that is compliant with their quality system requirements. ISO meets these required standards [3].


The European Commission recognizes ISO as a harmonized standard [1], so that becoming ISO certified conforms with the requirements of European medical device directives. Furthermore, in the U. February will mark the end of this 3-year transition period [6]. Furthermore, for the next two years until February , organizations will be able to gain accreditation for either the or version of ISO However, according to a draft guidance, after the second year, no new ISO certificates will be issued [6].

At the conclusion of the third year, any existing ISO certification will be invalid [2]. Therefore, in most jurisdictions, ISO certification is not an acceptable substitute for certification to the requirements of ISO Certification to ISO by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives.

In the U. Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO In addition, we are a leading global management certification body for quality management systems, including management systems applicable in the manufacture of medical devices.

Each audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system, and is headed by a lead auditor who will oversee the audit and any required management change notices. Finally, our on-site or off-site Technical Documentation Assessment will provide you with the information you need to understand your exposure to non-compliance issues.

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Our global network of more than dedicated medical health and services professionals include noted scientists and physicians recognised as authorities in their respective fields. Latest updates on ISO Certify your quality management system for medical devices with ISO Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons.

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