Integrating Clinical Evaluation and Risk Management 2012
10 May 2012
Webinar
Key Topics
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
Who should Attend
Regulatory Affairs Managers, Quality Managers, Management Representatives, Risk Managers, Notified Body Contacts and Design Engineers.
Past Events
Integrating Clinical Evaluation and Risk Management 2012 - 10 May 2012, Webinar (28694)
Integrating Clinical Evaluation and Risk Management 2026
Important
Please, check "Integrating Clinical Evaluation and Risk Management" official website for possible changes, before making any traveling arrangements
