Integrating Clinical Evaluation and Risk Management 2012 is a webinar that covers topics such as:
- Harmonized Standards, EU Directives
, NBOG Guidance Documents, EU Guidance Documents and GHTF Guidance Documents - The Overview
Risk Management, Clinical Evaluation, Their touch points The Documents and the Sources - Clinical Evaluation using MEDDEV 2.7/1
Stage 1 Identify the pertinent standards and clinical data, Scope, Stage 3 Analyze each individual data set, Stage 2 Appraise each individual data set and Report - Changes to the MDD
Clinical Evaluation changes in Annex I, Requirements for Clinical Evaluation and Clinical Evaluation changes in Annex X - Risk Management
Clinical Evaluation and Residual Risk, Status of ISO 14971, Joint follow-up for Clinical Evaluation and Risk Management - Clinical follow-up using GHTF/SG5/N4:2010
Design, Objectives, Implement and Study
Integrating Clinical Evaluation and Risk Management 2012 brings together Regulatory Affairs Managers, Quality Managers, Management Representatives, Risk Managers, Notified Body Contacts and Design Engineers.
