The objective of the course is to explain the medical device regulation 2017/745 in simple terms . The student will learn how to classify a medical device with examples, quizzes and guidance documents . This Course is broken into nine sections . The aim is to understand how Switzerland, Turkey and the EFTA are affected by the MDR . The course will also explain the implications of the EU commission rolling plan for the UK and the EU . It will also provide an overview of the European regulatory affairs for medical devices marketing in the EU. The course is designed to provide an understanding of the regulatory requirements and the requirements of post-market surveillance. It is also designed to teach students how to identify and understand the requirements and requirements of a device.Authentication failed. Unique API key is not valid for this user.
Who this course is for:
Medical Device Engineers
Quality control within the medical device industry
Operation Managers within the medical device industry
Entrepreneurs or small medium start-up companies that need to develop a new medical device.
Quality Control Technicians
Marketing within the medical device industry
Research and Development Engineers within the Medical device industry
Students in Biomechanical Engineering.
Students in Pharmaceutical science.
Students in Regulation affairs.
Students in Quality Assurance and quality control.
Internal and external auditors of the medical device Industry
Medical device manufacturers inside and outside of Europe.
Professionals engaged in ISO 13485 and Harmonised Standards within the European Union Market Place.
Small start companies who want to develop new products in the Medical device industry
Process and Development Engineers.
People managers within the Medical device and health care industry.
Students who need to really understand the medical device regulation 2017 745 in simple terms.
Health care providers. (Doctors and Nurses for example)
Professionals involved in pre clinical medical devices studies
Professionals involved in clinical trials of medical devices.
Professionals involved in Post market surveillance of medical devices.
Economic Operator The manufacturer.
Economic Operator The distributor.
Economic Operator The European Authorised Representative.
Economic Operator The Importer.
Economic Operator The Procedure Pack and Systems provider
File Name :
Medical Device Regulation 2017/745 EU regulatory affairs. free download