Changes to Medical Device Legislation, Adopting ISO 13485 to 21 CFR 820

March 20, 2024 - PRLog -- 21 CFR 820 contains the FDA 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. Join us to stay ahead of the curve and ensure your QMS meets the latest regulatory standards.

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Join Omnex Virtual Training in ISO 13485:2016 Lead Auditor Training for Medical Devices

Date & Location : Apr 15-19, 2024-Virtual-Pacific Time-US

Click here to Learn More: https://training.omnex.com/iso13485/iso-13485-2016-lead-auditor-training-medical-device-management-systems

Join Omnex for this important industry approach. This 5-Day ISO 13485 training course fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.