What Will FDA Harmonization with
ISO 13485:2016 Look Like?

Evaluating the Impact of FDA-ISO Alignment for Design Controls

ISO13485_Changes_Part2_WP_LPImageMarch 2019 marked the deadline for official recognition of medical device manufacturers coming into compliance with ISO 13485:2016: the new quality management system (QMS) standard. And—first announced in the spring of 2018—FDA has laid out intentions to harmonize its QMS regulations with the standard moving forward.

But what do this harmonization look like? And how does it affect one of the most critical pieces of FDA regulation for medical device manufacturers: Design Controls?

The second installment of our “How ISO 13485:2016 Implementation Will Impact Your Medical Device Development” white paper series will answer all these questions and more.

In Part II, learn about the primary differences between the latest iteration of ISO 13485 and FDA’s Design Controls Regulation, 21 CFR 820.30. The paper will help you identify what impact these differences could have on your organization and the precedent for anticipating certain changes.

Download the paper today and learn more about:

  • How the role of risk management could expand
  • The importance of the relationship between Design Controls and the total product lifecycle
  • Where computer software validation fits in the scheme of harmonization

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