Following its ratification by the European Parliament, the Medical Devices Regulation will constitute major changes for the industry and is expected to become fully applicable in mid 2020. This 2-day introductory-level training course will examine the requirements outlined in the new Regulation as well as the existing Directive.
Major topics you will examine include classification, conformity assessment routes, risk management, post marketing adverse event reporting and labelling. Delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.
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.