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:
Who Will Benefit:
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.
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.If you have any concern about the content of the webinar and not satisfied 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).
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