Clinical Evaluation for Medical Devices
UK Live Online Training (GMT)
- Starts 25 Jan 2022Starts 25 Jan 2022
- 895 British pounds£895
- Online Virtual Classroom
Course Overview Our industry leading experts will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system. Our team performs clinical evaluation reviews for notified bodies, allowing us to give you insights into the common pitfalls. This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials. Course Agenda Module 1 - What is Clinical Evaluation? - Definitions and Key Terminology - Clinical Evaluation and the MDR - What has changed under the MDR? - Post Market Clinical Follow-up (PMCF) Module 2 - Guidance for Clinical Evaluation - Links to other processes - Clinical Data Evaluation Module 3 - Clinical Evaluation Plan - Plan Objectives, Sources of Data & Claims - ERs/GSPRs Module 4 - Literature Search & Databases - State of the Art - Getting your questions right - Clinical Evaluation Competencies - Identification of Data - Appraisal & Analysis Module 5 - Risk of Bias - Meta Analysis - Clinical Evaluation Report - Clinical Investigation - Ethics & Consent - Best Practice - The NB Perspective What's included? - 2 days of live online training - Slides and handouts - PDF certificate - Browser-based, no downloads required - Join in polls, tests and breakout rooms - Q&A session What you need: ▪ Internet access with Google Chrome ▪ Access to a microphone (Webcam not required) Who should attend? This 2-day course has great value for anyone involved in implementing or maintaining a clinical evaluation file. - Quality Engineers - Quality Managers - Regulatory Professionals - Clinical Data Evaluators - Clinical Sponsors Discounts are available for 3+ attendees. Please email us at firstname.lastname@example.org for your unique discount code to use at the checkout.
Places are non-refundable. Substitutions may be made at any time at no additional charge.
Meddev Solutions, 30 Monaghan Street, Newry Co. Down, BT35 6AA, N.Ireland GBR