The Medical Device Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.

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

This course is designed to give you insights into how Notified Bodies may perform an MDR QMS compliance audit, using the topics of a typical MDR audit agenda as the basis. This will enable you to optimize your auditing skills and knowledge to boost your audit capabilities, gain confidence in planning and performing an effective EU MDR QMS audit, as well as ensuring continued compliance to the EU MDR (2017/245).

Course Aim:

This course aims to help you to perform audits of the medical device quality management systems against the relevant requirements of the European Medical Device Regulations (EU MDR 2017/245).

How will I benefit?

This course will help you:

• Perform audits against the EU MDR (2017/245) Quality Management System requirements.
• Ensure continued compliance against the EU MDR (2017/245) QMS requirements.

What will I learn?

• Establish the relationship between the ISO 13485:2016 and the EU MDR (2017/745)
• Recognize and interpret the key QMS requirements of the EU MDR (2017/745)
• Appreciate that the range of medical device classifications mean differing requirements in the context of auditing
• Plan for and conduct EU MDR (2017/745) QMS audits to establish and maintain compliance against these requirements.
• Report on any identified nonconformities.

Who should attend?

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 Medical Device manufacturers g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee

Please note: This course will not cover audit requirements for In Vitro Diagnostics Devices or focus on devices with specific requirements.

Duration

3 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Already a competent auditor in the medical device industry and especially familiar with the auditing requirements of ISO 13485:2016.

You must have a good understanding of the requirements of the MDR. You should also have experience with quality management systems for the medical device industry. Recommended to have either attended the ISO 13485 Lead auditor or ISO 13485 internal auditor course.

Related training

ISO 13485:2016 Lead Auditor
ISO 13485:2016 Internal auditor
MDR one-day requirements course and three-day implementation course
IVDR courses and specific courses are available on clinical evaluation, and risk management.