Tuesday, 02 January 2024 12:17 GMT

Non-Conformance And Corrective Action For Medical Device Manufacturers: Stay Ahead Of ISO 13485, 21 CFR 820 And Other Regulations (ONLINE EVENT: June 19, 2026)


(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities lie in developing training programs and consulting services to help medical device manufacturers comply with ISO 13485 and 21 CFR 820, particularly focusing on effective identification and management of non-conformances to enhance regulatory adherence and quality assurance.

Dublin, April 15, 2026 (GLOBE NEWSWIRE) -- The "Non-Conformance and Corrective Action for Medical Device Manufacturers (June 19, 2026)" training has been added to ResearchAndMarkets's offering.
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS).

Regulations for medical device quality management systems include particular requirements for non-conformance, correction, corrective and preventative actions. These requirements relate to non-conformances identified through internal audits, external audits, routine processes, customer complaints vigilance and many other activities. Evidence of a QMS which deals with non-conformance and prevents recurrence is important and expected when demonstrating conformity with the regulations.

These requirements are defined in ISO 13485, the international standard for medical device quality management systems, as well as in 21 CFR 820 and other global regulations.

This course provides an introduction to these regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

Who Should Attend:

  • Managers and supervisors working within a regulated Quality Management System (QMS)
  • Regulatory Compliance specialists
  • Quality Management System (QMS) specialists
  • Internal Auditors
  • Regulatory and Quality professionals

Speakers

Annette Callaghan

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years' experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

For more information about this training visit

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