In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety & performance. Examples of medical devices range from something as simple as a syringe, to as complex as a life support machine.
Whether you are completely new to regulatory affairs or are branching out from other areas of the wider medical device industry, this introductory-level course will detail the EU regulatory requirements throughout the entire product life-cycle.
Complemented with practical exercises and open discussions, you will gain a comprehensive overview of the essential European regulatory requirements to consider as you prepare for MDR implementation in 2020, including; the European regulatory landscape, device classification and conformity assessments, documentation and labelling requirements, post-market considerations, risk management and clinical evaluations.
Delegates will also be provided with additional time to discuss the implications of Brexit.
Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously worked for BSI Product Certification as a medical devices notified body Certification Manager, managing BSI’s regulatory compliance for CE marking to the Active Implantable Medical Devices Directive 90/385/EEC and Medical Device Directive 93/42/ECC. In addition, Anne worked worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Unit.
The course was very interactive with lots of opportunity to ask questions. It provided an excellent overview.
I was looking for a course which would inform and prepare me for the new MDR. The fact that we could ask questions that arose at any time was great; I enjoyed this course immensely.
The fact that it was a small group gave us the opportunity to discuss everything with good informal contact with the trainer.
Comprehensive course on New Regulation covering range of topics.