Webinar: “Changes to Medical Device Legislation, Adopting ISO 13485 to 21 CFR 820”
Date and time: March 28, 2024, 11:00 a.m. Eastern
Speakers: Michael Checketts
With the release of the Automotive SPICE PAM and PRM v4.0 on Nov. 29, 2023, among the news was that new process groups were added. In this event, we will go more into the details of one of these, the Hardware Engineering Process Group (HWE).
21 CFR 820 contains the U.S. Food and Drug Administration requirements for quality management systems (QMS). These requirements have been established since July 1978. The FDA has recently amended this regulation to align more closely with QMS requirements used by other global regulatory authorities. The purpose of this presentation is to familiarize attendees with these changes. Stay ahead of the curve and ensure your QMS meets the latest regulatory standards.
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Key ideas to discuss:
• ASPICE plug-in concept for engineering processes
• Overview of the HWE processes
• Showing the changes to the other engineering processes made to encompass HWE in the ASPICE v4.0
• Description of the impact that HWE has on nonengineering processes and how this is implemented in ASPICE v4.0. This event will be held in the English language.