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Course code
PR371
Course code
Duration
Minimum of 40 hours
Category
Auditing
Level
Professional
Scheme(s)
Medical devices
MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System)
This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

IRCA Medical Devices Quality Management Systems Certification Scheme
Published: 18 Aug 2016
The IRCA Medical Devices Quality Management Systems (MDQMS) Certification Scheme is for auditors working with ISO 13485.