Are you ready for the new Medical Device Regulation (MDR)?
In May 2017, the EU issued the new MDR to address weaknesses in the current law relating to medical device safety. As we are quickly approaching 2020, time is running out for the industry to begin facilitating the necessary changes relating to device classification, clinical evidence and safety reporting to remain compliant. This 9-module course will bring you up-to-speed with the fundamentals of the new MDR and the changes you need to understand to avoid costly delays and ensure quick market access for your medical device. Whether you are new to the medical device industry, or simply need an overview of the changes, then this course will provide you with all you need to know regarding the EU regulatory landscape.
This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:
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 Uni
MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Once you have registered and made the full payment, you will be given login details to access the course.