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ISO 13485:2016 and FDA Program Changes

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Webinar Title:ISO 13485:2016 and FDA Program Changes


The 2016 revision to ISO 13485 was released in March, this is the first revision of the standard since 2003. This revision is significant for many reasons including participation in the revision process by a number of regulatory bodies including the FDA.

Regulatory involvement has resulted in the word "regulatory" appearing 60 times in the new standard, compared to 16 times in the old version. Much of the restructuring, text, and scope modification has been done to facilitate regulatory requirements. ISO 13485:2016 could be touted as a regulatory standard for many reasons including the title, scope and documentation requirements. Furthermore, ISO 13485:2016 was developed to be much more aligned with 21CFR 820 FDA requirements.

The MDSAP or the Medical Device Single Audit Program was developed to allow qualified third party registrars to conduct a single audit that could satisfy the requirements of multiple regulatory agencies globally. Not only can the audit satisfy regulatory requirements, but at the same time it can provide ISO 13485 management systems audits, thus making audits and regulatory inspections more efficient. The MDSAP program is currently built around ISO 13485:2003 but will soon embrace ISO 13485:2016. The MDSAP is truly revolutionary and will result in only one audit with reciprocal acceptance by the US, Canada, Australia, Brazil, and Japan. Each regulatory body will be using the results to varying degrees.

Please join this Omnex webinar to gain a better understanding of the implications of the ISO 13485:2016 changes, MDSAP, and FDA standards. We will cover expectations and insights from integrating the FDA and ISO 13485:2016 requirements for software validation, Unique Device Identifier, CAPA, complaints, training and human factors.

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