EU Medical Device Regulation (MDR) 2017/745 QMS Auditor Training Course

Course Details

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 ensuring continued compliance to the EU MDR (2017/245).

This instructor-led two-day virtual training course provides practical instruction for auditors undertaking internal and supplier audits for the European Medical Device Regulation (EU MDR). The course describes the regulation in depth from the auditor’s perspective and provides practical instruction for planning and conducting audits. Electronic hand-outs of training materials and case studies are provided prior to the class.

Why Is This Important?

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

Manufacturers must ensure that their internal auditing teams have the right competency, knowledge and experience to navigate through an MDR internal audit and it is therefore, imperative that they are able to perform audits against the requirements of the QMS MDR.

Who Should Attend?

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU MDR. Students should have some internal audit experience and ideally have auditor qualifications based on ISO 19011 and have conducted QMS audits related to ISO standards and other regulations.

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) and related legislation and implementing acts.

This course will help you:

• Recognize the primary elements of the European Medical Devices Regulation 2017/745 (EU MDR) and:
• Perform audits against the EU MDR (2017/245) Quality Management System requirements.
• Ensure continued compliance against the EU MDR (2017/245) QMS requirements.
• Understand Key Players in the EU
• Prepare audit plans that clearly represent a EU MDR audit

What will you learn?

• Plan and conduct internal audits against the requirements of the EU MDR 2017-745
• Identify conformity and non-conformity against the specific articles and annexes of the regulation
• Understand linkage between the EU MDR, MDCG Guidance, Implementing acts
• Economic Operators – obligations and supplier contracts
• Understand compliance requirements under SoTA (State of the Art)
• Audit and review GSPRS to ensure compliance and proper supporting documentation
• Understand and audit the changes control program for legacy and new devices
• Understand and audit the system for controlling documents of external origin and impact assessment requirements to include understanding what a harmonized standard is, the application and purpose of Annex Z, MDCG Guidelines, how MDR is updated via implementing acts, delegated acts and their meaning
• Audit content requirements of Technical Documentation under Annex II and III
• Recognize specific requirements relative to manufacturer obligations
• Review and understand requirements under Article 10 and conformity assessment routes
• Review PMS programs, understand requirements for PMCF, CER, PSURs.
• Develop an audit plan that captures detail elements under the EU MDR.
• Hand on experience with case study and review of GSPRs and TD.
• Purpose and scope of EN ISO 13485:2016+A11:2021 and EN ISO 14971:2019+A11:2021 within the context of the EU MDR under Article 10 and Annex IX and Xl