MDR Expert Training Course - TÜV Complete Package
Our compact training on "MDR-Expert – TÜV" offers you comprehensive training for the implementation of EU Regulation 2017/745 MDR. You will learn about the regulatory requirements of the MDR and understand the changes that your company must cope with in a timely manner. To get started, you will be given an overview of the requirements of the MDR.
The post-market surveillance system becomes one of the central building blocks of your process map with important interfaces to PMCF and clinical evaluation. The new Medical Devices Regulation (2017/745) also makes UDI requirements mandatory for medical device manufacturers in the EU. You will gain knowledge of the responsibilities and obligations involved in the introduction of UDI, including European specificities.
Another important part of the compact training on the "MDR-Expert – TÜV" is the function of the PRRC, the person responsible for compliance with regulatory requirements according to Article 15 of the MDR. You will learn which activities this function involves and how you can design communication to and from the PRRC in the company.
With successful completion of the examination as "MDR-Expert – TÜV", you prove your knowledge for the latest regulations of medical technology and enable your company to successfully and safely bring medical devices to market even after the MDR comes into force. Since the training content for the "Responsible Person according to Article 15 MDR" is included, you will also receive the certificate "Person Responsible for Regulatory Compliance (PRRC)" according to Article 15 MDR.
- Manager Regulatory Affairs, Quality Management Officer, Head of Research & Development, Safety Officer/PRRC
- Managing directors, importers, distributors, medical device consultants, EU representatives, employees in supervisory authorities, consultants
- You prove that you know the regulatory requirements from the MDR and understand the changes that your company has to cope with in a timely manner
- You are able to help ensure that your company makes changes to the QM system in order to map internal and external processes in compliance with MDR
- They are familiar with the post-market surveillance system and the essential requirements for UDI and EUDAMED
- You will find out what activities the person responsible for regulatory compliance ("PRRC") according to Article 15, MDR involves
- The training attendance supports you in proving your professional qualification within the framework of the MDR certification of your company
- Medical Device Regulation (MDR) in detail
- Basics and contents of the Medical Device Regulation (MDR), classification
- Medical Device Regulation (MDR) - Implementing requirements in the quality management system
- Necessary contents of a quality management system compliant with the MDR
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) of Medical Devices
- New regulations for PMS/PMCF according to the MDR
- Unique Device Identification (UDI) in detail
- Regulatory requirements for UDI and the implementation of requirements for UDI
- Person Responsible for Regulatory Compliance (PRRC)
- Requirements and scope of the PRRC
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Upon passing the exam you will receive your globally recognised TÜV SÜD certificate on "MDR-Expert".
TÜV SÜD additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].