International Medical Devices Industry: FDA to Transition to ISO 13485

The U.S. Food and Drug Administration has announced that it will transition to ISO 13485:2016 after conducting a comparative analysis between the latter and the current Quality System Regulation (QSR).  

In an official update from the FDA in December 2018, the reasons for and benefits of implementing ISO 13485 as the benchmark for quality management system audit inspections are outlined. In the presentation, the agency states: “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.

The FDA also recognizes that there will be implications not only for FDA itself, which will have to retrain its inspectors and other staff as well as adapt its audit inspection requirements, but also for medical device production companies in the U.S. – especially those which have not been certified against ISO 13485:2016 before.

The transition to ISO 13485:2016 from the FDA will come alongside the coming into force of the MDSAP (Medical Device Single Audit Program) as conceived from the IMDRF (International Medical Device Regulators Forum) and EU MDR 2017/45 (the Regulation of the European Parliament and of the Council). The transition is about to happen soon, but impacted organizations will be able to adjust as long as they conduct the necessary management system changes, gap analyses, and internal audits.

Crest Advisory Africa is here to help individuals to get trained and certified and organizations to get audited and certified against ISO 13485

3 Responses

  1. Hi
    Thanks for the great feedback.
    We appreciate it a lot.
    There are view horror stories about medical devices and the regulatory requirements regarding these.

    Please check out the article we have send out this morning. This is very interesting in terms of Personal Identifiable Information (PII). Here is the link: https://www.crestadvisoryafrica.com/iso-27701-2019-pims-international-certification-to-protect-personal-identifiable-information-pii/
    Please also look at the video which has a link in the article.

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About the Author

Nico Snyman
Founder and CEO at Crest Advisory Africa (Pty) Ltd Nico Snyman is the Founder and Chief Executive Officer (CEO) of Crest Advisory Africa (Pty) Ltd since June 2014, based in Johannesburg, South Africa. Nico has an MBA, specializing in Total Quality Management (TQM) and is an internationally Certified Management System Auditor with PECB. Nico is also a PECB-certified Senior Lead Auditor for 19 ISO standards. With over 35 years of experience in various disciplines, Nico has a vast subject matter expertise (SME) base across various industries, from government, corporate, regulators, banks, mines, medical schemes, etc. He served as a Brigadier in the South African Police Service (SAPS), an Executive on the biggest global project between 2007 and 2011, the Gautrain Project, and as an Executive, was instrumental to the establishment of the Bombela Operating Company (BOC) between 2009 and 2013.