How to write a Clinical Evaluation
Instructor:
Rebecca Kemble
Product ID: 705592
- 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, including the information presented in the Clinical Evaluation Report. This course will discuss the requirements that manufacturers of medical devices must follow in order to comply with the Regulation and to be prepared for the increased scrutiny by the Notified Body.
The aim of the course is to help you develop a greater understanding of how to prepare a Clinical Evaluation Report. The MDR and meddev 2.7.1 rev 4 will be discussed to support Manufacturer’s compliance with EU requirements.
Areas Covered in the Webinar:
- Updates on EU Regulations and their impact on CERs (Clinical Evaluation Reports)
- Overview to preparation of the Clinical Evaluation Report – the 5 key stages
- Sources of clinical data – clinical literature review
- How to assess and analyse the clinical data to meet the new expectations
- Conformity with the essential requirement Meddev 2.7.1 rev 4
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.
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