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).
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.
Pedagogical objectives
- Perform audits against the EU MDR (2017/245) Quality Management System requirements
- Ensure continued compliance against the EU MDR (2017/245) QMS requirements
- Be confident that your organization can rely on competent EU MDR (2017/245) auditors
Skills to be acquired
By the end of the course you’ll be able to:
- 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
Targeted Audience
- 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
Pedagogical, technical and framing means
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
