Complementary 30-MINUTE WEBINAR: Medical Device Change Control

Description:

FDA vigilance regarding post-market medical device changes is creating a high-stakes environment for manufacturers. Companies often find the decision of when a device modification requires a new 510(k) submission to be a difficult and ambiguous compliance minefield. This 30-minute session will cut through that ambiguity by identifying the three core types of changes—Manufacturing, Labeling, and Performance—that the FDA is actively scrutinizing under the K97-1 framework and the 2017 Guidance. Learn the absolute minimum standard for documenting your rationale to stay compliant and defend your decisions during an audit.

What You Will Learn (The Critical Need-to-Knows):

⦁ The Compliance Gap: Why relying on outdated or internal processes for change control is no longer a defensible strategy under current FDA guidelines.

⦁ Three High-Risk Change Areas: Pinpoint the specific areas (Materials, Labeling, and Tech/Performance) where even a small modification can quickly trigger the requirement for a new 510(k).

⦁ Defensible Rationale: The fundamental requirement for documenting your decision not to file a new 510(k), ensuring your file is ready for inevitable FDA review.

Who Should Attend:

Regulatory Affairs, Quality Assurance, and Engineering Leaders responsible for change control and compliance documentation.