EU IVDR 2017/746 QMS Auditor Training Course

Level Internal auditor Duration 3 days

Available to book: Live online training Request a quote

The In Vitro Diagnostic Medical Device Regulation (IVDR) is the legislation detailing the requirements that manufacturers must meet to place in vitro diagnostic medical devices on the market in the European Union.

As more and more manufacturers now hold IVDR Quality Management System (QMS) certificates, it’s essential for continued compliance that they are able to perform audits against the requirements of the IVDR QMS.

This course is designed to give you insights into how Notified Bodies may perform an IVDR QMS compliance audit, using the topics of a typical IVDR audit agenda as the foundation. This will enable you to enhance your auditing skills and knowledge, build confidence in planning and conducting effective EU IVDR QMS audits, and support ongoing compliance with the EU IVDR (2017/746).

How will you benefit?

This course will help you to:

Perform audits against the EU IVDR (2017/746) Quality Management System (QMS) requirements
Ensure continued compliance against the EU IVDR (2017/746) QMS requirements
Be confident that your organization can rely on competent EU IVDR (2017/746) internal audits

By the end of the course, you’ll be able to:
- Establish the relationship between the Quality Management System standard ISO 13485:2016 and the EU IVD Regulation (IVDR) 2017/746
- Recognize and interpret the key QMS requirements of the IVDR
- Appreciate that there are differing requirements depending upon your in vitro diagnostic device risk classification and what that means in the context of auditing
- Plan for, and conduct IVDR QMS audits to establish and maintain compliance against these requirements
- Report on any identified nonconformities
The course is especially suitable for:
- RA, QM, and QA professionals who already perform audits
- Anyone concerned with certification or active in projects for CE-marking, especially involved in the QMS implementation side
- Staff involved in audits and working for organizations that partner with IVD manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
- Please note: This course will not cover audit requirements for Medical Devices or focus on devices with specific requirements.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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