Are you ready for the new Medical Device Regulations (MDR)?
Published on May 5th 2017, the final text of the Medical Devices Regulation constituted major changes for the industry. This flexible online course offers students an excellent opportunity to understand the basics of the entire medical device product lifecycle in the context of these updates.
This course will allow you to engage with a leading expert in the field and come to grips with regulatory affairs, quality management systems, risk management, clinical evaluation requirements and general compliance aspects of medical devices.
The new MDR necessitates a degree of transformation for medical devices manufacturers, importers and distributors, including changes to classification and safety and performance requirements for proving compliance, among others. Designed for those new to medical devices, or needing a broad overview of the changes resulting from the MDR, this course will cover a variety of major topics to give an excellent understanding of the area.
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.