As Manager Regulatory Affairs International – TÜV you are responsible for the registration of medical devices on international markets. You will ensure that all directives, laws, standards and country-specific requirements regarding product registration and approval are taken into account. Module 1 includes the training as Manager Regulatory Affairs – TÜV. You will show your competence in the areas of Medical Device Registration (MDR) and management systems (ISO 13485) and will be able to carry out approvals for medical devices in the European Economic Area. You are familiar with the regulatory requirements for clinical evaluation, risk management according to ISO 14971 and the contents of technical documentation. Module 2 qualifies you to advance the approvals on the most important international markets. As Manager Regulatory Affairs International – TÜV, you will be familiar with the different approval and framework conditions in the most important target markets. You will learn to correctly interpret the new MDSAP audit model and know which new aspects have to be considered by the manufacturer in order to prepare successfully for an MDSAP audit.
Module 1: Manager Regulatory Affairs – TÜV (6 days)
- Basic course in medical device law – regulatory framework according to MDR
- Current legal framework for medical devices in Europe (MDR)
- Basic requirements, CE marking
- Technical Documentation
- Management systems for manufacturers
- Construction, application of ISO 13485:2016
- Clinical evaluation of medical devices
- Clinical trial, protocol, ethics committee
- Risk management and risk analysis for medical devices
- Contents of ISO 14971, risk analyses
- Practical implementation workshop
Module 2: Manager Regulatory Affairs International – TÜV (5 days)
- Approval of medical devices in Canada, Brazil, Mexico, Australia
- Approval of medical devices in Asia
- Approval of medical devices in the USA
- Medical Device Single Audit Program (MDSAP) – Requirements and Preparation
Who should attend
- Newcomers in the medical device industry
- Expert and executive personnel to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
- Consultants in the medical device industry
Certificate TÜV SÜD Academy
The seminar content corresponds to the current status of revision/harmonisation. A pocketbook Medical Device Regulation (MDR) is included in the seminar price.
TÜV SÜD Academy senior expert trainers
- Obtain high-class training and qualify as Manager Regulatory Affairs International – TÜV in a very short time.
- Gain an overview of all important parameters in the medical device industry.
- Familiarise yourself with worldwide registration requirements for medical devices.