Overview of Medical Device Regulation in Europe
Instructor:
Rebecca Kemble
Product ID: 705566
- Duration: 90 Min
Why Should You Attend:
The Medical Device Regulation (MDR), which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) will come into effect in May 2020. The new MDR requires significant changes to the clinical evidence that Manufacturers must document, with more clinical data being required for higher class devices. This course will discuss the requirements that manufacturers of medical devices must follow in order to comply with the Regulation.
The aim of the course is to help you develop a greater understanding of the medical device regulations for the manufacturers of Medical Devices. The course will also provide tools and references to ensure that companies are able to comply with the new MDR.
Areas Covered in the Webinar:
- Introduction to Medical Device Regulation in Europe – background
- Updates on the Regulations and their impact on CERs (Clinical Evaluation Reports)
- How to design Clinical Trials, including how the MDR will affect post market clinical studies for existing products
Who Will Benefit:
- Quality managers
- Regulatory affairs
- Manufacturers
- Clinical managers
- Product development managers
- Project managers
Rebecca Kemble
Freelance Consultant, Acclaim Biomedical Consulting Ltd
Rebecca Kemble is an experienced senior Clinical Research Professional and has worked for over 10 years, with a leading global Orthopaedic Medical Device manufacturer. During this time gained significant experience in International Post Market Clinical Follow-up and Regulatory Studies. During this time she was a Project Manager for a number of studies;; focusing on study design, recruitment and selection, study conduct, data analysis, writing reports, and liaison with Investigators/Surgeons.
More recently Rebecca has worked for a Clinical Research Organisation (CRO) covering a wide variety of therapeutic areas including Oncology, CVD, COPD, Alzheimer’s disease, Rheumatoid Arthritis, Epilepsy, Multiple Sclerosis, and Cystic Fibrosis.
Rebecca gained a PhD in 2010 which investigated the impact of antioxidants on intestinal cancer.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
