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
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
Speakers
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.
