ISO 13485:2016

Finalized in first quarter of 2016, ISO 13485:2016 is one of the most prominent changes within the medical device industry. ISO 13485:2016 specifies requirements for a quality management system to ensure compliance with appropriate standards and impacts companies involved in any stage of the medical device life cycle. Companies do not need to implement this new standard until February 2019; however, it will take substantial time and effort to do so. Quality and regulatory professionals should not delay their assessment of ISO 13485’s impact and should begin the implementation process now.

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The European Union Medical Device Regulation (EU MDR/IVDR) recognizes historical medical device problems and aims to strengthen regulatory requirements and oversight to foster a more FDA-like regulatory environment. While medical device companies have until 2020 to make the EU MDR transition, it’s important to start the implementation process as soon as possible in order to allow enough time to generate sufficient clinical evidence and adhere to the other required changes by the mandatory deadline.

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The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that covers the requirements of several jurisdictions instead of undergoing several audits. This program satisfies all pertinent regulatory parties for medical device companies and encompasses a standardized, global approach to auditing with a focus on reducing the regulatory burden faced by the medical device industry.

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MedAccred is an industry-managed supplier quality accreditation program focused on critical manufacturing processes, with objectives of enhancing patient safety, improving product quality, and assuring compliance with applicable requirements. It is gaining tremendous traction throughout the medical device industry, with more and more suppliers taking advantage of the benefits that come from achieving MedAccred accreditation.


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