By the end of the course you’ll be able to: Explain the requirements, scope and the structure of ISO 13485:2016 Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR Establish the relationship between the ISO 13485:2016 and the EU MDR (2017/745) Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization Identify the systems that are required to implement an ISO 13485:2016 QMS Describe the key steps of a conformity assessment Recognize and interpret the key QMS requirements of the EU MDR (2017/745) Communicate the key requirements and concepts within the Regulation Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate) Recognize and interpret the key QMS requirements of the EU MDR (2017/745) Plan for and conduct EU MDR (2017/745) QMS audits to establish and maintain compliance against these requirements Recognize the requirements for post-market surveillance and updates Develop a strategy for regulatory compliance as stipulated by MDR Implement requirements concerning the Conformity Assessment including: Fulfil Technical Documentation requirements, plan post-market activities Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking Report on any identified nonconformities EU MDR QMS Lead Auditor qualification courses includes: ISO 13485 Lead Auditor Practitioner (5 days virtual classroom + 4 hours on-demand elearning) ISO 14971:2019 Risk Management for Medical Devices: Requirements (1 day virtual classroom) Implementation of the Medical Device Regulation 2017/745 (MDR) for CE Marking (3 days virtual classroom) EU Medical Device Regulation (MDR) 2017/745 – QMS Auditor (3 days virtual classroom)

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 e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee Please note: This qualification will not cover audit requirements for In Vitro Diagnostics Devices or focus on devices with specific requirements.

Each module is followed by a mandatory online examination. Delegates must pass the examination to be awarded the qualification.

On completion, you’ll be awarded a internationally recognized BSI Training Academy certificates for each course, an overall qualification certificate and a BSI Mark of Trust that can be used in communications and on social media.

EU MDR QMS Lead Auditor Practitioner

Level Practitioner Duration 12.5 days

Available to book: Virtual classroom Contact us for booking

Can’t find the right courses or dates?

Get our full schedule and training guide, or talk to our training advisor for assistance.

Find out more

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

This qualification is designed to optimize your auditing skills and knowledge to boost your audit capabilities and gain confidence in understanding, planning, performing and managing an effective EU MDR QMS audit in line with ISO 13485:2016 and ISO 19011, as well as ensuring continued compliance to the EU MDR (2017/245) and that establishes conformity and enhances overall organizational performance.

How will I benefit?

Successful completion of this qualification, will allow you to demonstrate:

Understand the key requirements and concepts of the European Medical Devices Regulation
Implement the requirements of the European Medical Devices Regulation
Communicate the impact of the key requirements introduced by the MDR to your organization
Guide and support other people and partner organizations affected by MDR
Set up and update required documentation
Take the necessary steps for your organization to meet the MDR requirement
Maintain compliance to MDR and other/future documents related to Medical Device legislation
Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts, standards)
Perform audits against the EU MDR (2017/245) Quality Management System requirements
Ensure continued compliance against the EU MDR (2017/245) QMS requirements

Most of the training courses in this qualification are HRD Corp Claimble Course.

Which qualification will I achieve?

On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared across within your organization and across your network of contacts.

By the end of the course you’ll be able to:
- Explain the requirements, scope and the structure of ISO 13485:2016
- Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR
- Establish the relationship between the ISO 13485:2016 and the EU MDR (2017/745)
- Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
- Identify the systems that are required to implement an ISO 13485:2016 QMS
- Describe the key steps of a conformity assessment
- Recognize and interpret the key QMS requirements of the EU MDR (2017/745)
- Communicate the key requirements and concepts within the Regulation
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Recognize and interpret the key QMS requirements of the EU MDR (2017/745)
- Plan for and conduct EU MDR (2017/745) QMS audits to establish and maintain compliance against these requirements
- Recognize the requirements for post-market surveillance and updates
- Develop a strategy for regulatory compliance as stipulated by MDR
- Implement requirements concerning the Conformity Assessment including: Fulfil Technical Documentation requirements, plan post-market activities
- Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking
- Report on any identified nonconformities
EU MDR QMS Lead Auditor qualification courses includes:
- ISO 13485 Lead Auditor Practitioner (5 days virtual classroom + 4 hours on-demand elearning)
- ISO 14971:2019 Risk Management for Medical Devices: Requirements (1 day virtual classroom)
- Implementation of the Medical Device Regulation 2017/745 (MDR) for CE Marking (3 days virtual classroom)
- EU Medical Device Regulation (MDR) 2017/745 – QMS Auditor (3 days virtual classroom)
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 e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
Please note: This qualification will not cover audit requirements for In Vitro Diagnostics Devices or focus on devices with specific requirements.
Each module is followed by a mandatory online examination. Delegates must pass the examination to be awarded the qualification.
On completion, you’ll be awarded a internationally recognized BSI Training Academy certificates for each course, an overall qualification certificate and a BSI Mark of Trust that can be used in communications and on social media.

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch