On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.
On February 23, 2022, the agency proposed an amendment to 21 CFR 4 and 820. The purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485: 2016 (the Standard), used by other regulatory authorities. This will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs.
Boznik’s presentation will include information directly from key individual within the agency on what expectations will be for current activities for the greatest impact toward compliance with the new requirements.
Topics will include:
- What has led FDA to this announcement.
- Differences in 21 CFR 4/820 and ISO 13485:2016.
- What FDA is saying about the adoption of ISO 13485:2016.
- How to plan for needed changes.
- How certification to MDSAP changes helps you in the transition.
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