Stay current with FDA expectations by learning the details of the latest technical amendments to medical device regulations. This course explains the editorial updates that revise and standardize references in 21 CFR to align with the QMSR Final Rule, harmonizing with ISO 13485:2016. It clarifies what’s changed, what remains the same, and how to maintain compliance. Ideal for professionals responsible for regulatory submissions, quality documentation, or compliance in the device sector.
In this course you will learn the following:
* Understand the purpose and scope of the technical amendments to 21 CFR Parts 801, 803, 812, 860, and related device regulations.
* Identify the key changes made to regulatory references and terminology to align with the QMSR.
* Recognize the effective date and compliance expectations for the amended regulations.
* Appreciate the non-substantive nature of these amendments and their impact on compliance.
* Understand the consequences of non-compliance with existing requirements as clarified by the amendments.
