In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2.5 hours online.
All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.
Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety & performance. To maintain patient safety the EU introduced the Medical Device Regulation (MDR) transforming and modernising the older Directives. Whether you are new to regulatory affairs, the MDR or are branching out from other areas of the wider medical device industry, this fundamental-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, including: the European regulatory landscape, device classification and conformity assessments, documentation and labelling requirements, post-market considerations, risk management and clinical evaluations.
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
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 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.