Medical Device – Quality Management Systems

In response to increasing demand, the CQI and IRCA has developed a new training course scheme for medical devices and the EU MDR (Medical Device Regulation) regulatory requirement.

The Medical Device – Quality Management System (MD-QMS) scheme will provide auditor training across all the CQI and IRCA levels, with additional regulation courses for those who need them.

The new MD-QMS courses will be added to the CQI and IRCA’s long-standing portfolio of certified courses that its Approved Training Partners (ATPs) continue to deliver.

They will cover auditing against ISO 13485, EU MDR 2017/745, and the Medical Device Single Audit Program (MDSAP).

The full list of core MD-QMS ISO 13485 Auditor courses include:

• MD-QMS ISO 13485:2016 Foundation (FD132)
• MD-QMS ISO 13485:2016 Internal Auditor (PT264)
• MD-QMS ISO 13485:2016 Lead Auditor (PR369)
• MD-QMS ISO 13485:2016 Auditor Conversion (PR370)

Meanwhile, the regulatory requirement courses include:

• MDSAP Auditing Approach (PT221)
• MD-QMS Comprehensive EU MDR 2017/745 Practitioner (PT219)
• MD-QMS EU MDR 2017/745 Auditor (PR371)

These new offerings are a great opportunity for individuals and organisations who need to gain an understanding of the ISO 13485 standard and regulatory requirement EU MDR, and confidence that undertaking a CQI and IRCA Certified ISO 13485 Auditor training course will ensure they are trained in the actual requirements of the standard and regulation.