Medical Device Compliance with MEDDEV 2.7.1 Rev 4 for Clinical Evaluation / CER Reporting
Wednesday, 13 June 2018 10:00 AM PDT, 01:00 PM EDT
Training Duration = 60 min Sponsored by Online Compliance Panel
Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by notified bodies and competent authorities in Europe.
That scrutiny - and the burdens placed on medical device manufacturers - leaves some companies at risk of losing their CE certifications following routine notified body re-certification audits.
In this training, we will examine the clinical data and literature review requirements found in MEDDEV 2.7/1 revision 4 as well as the changing regulatory environment as it relates to these requirements.
Why Should You Attend:
Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.
Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully. If you have existing CERs, you need to develop an action plan to identify and address the gaps. If you will be CE marking a new device, you must ensure you have sufficient clinical data to show compliance with the essential requirements for safety and performance.
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously,She worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH.
She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission.
She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.