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The ISO 14071 standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485.
Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production. In 2012, a European harmonized version of this standard was adopted by the European Committee for Standardization (CEN) as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices , and In-vitro Diagnostic Medical Device Directive , and Active Implantable Medical Device Directive.
Why should you Attend:
There are outstanding tools in the ISO 14971, but they are not used adequately by many medical device companies. Most companies use only one or two tools out of the five tools. The most important tool, the Preliminary Hazard Analysis, is hardly used. A company with a high risk device must use all the five tools. This webinar will show how to use all five tools with a return on investment of at least 1000%.
Areas Covered in the Session:
Overview of ISO 14971:2012 standard, definitions and terms
how to conduct risk management activities to remain compliant.
GHTF Guidance "Implementation of Risk Management Principles and Activities within a Quality Management System."
Lifecycle of Risk
Risk Management File & Plan
Identification of harms, hazards and hazardous situations
tools and techniques
Preliminary Hazard Analysis (PHA)
Failure Mode and Effects Analysis (FMEA)
Fault Tree Analysis (FTA)
HAZOP (Hazard an Operability study)
HACCP (Hazard Analysis and Critical Control Point)
Risk Control and Reduction
Residual Risk Evaluation
Risk Report including the risk benefit analysis
Production / Post Production Requirements as part of ongoing Post Market Surveillance activities
Who Will Benefit:
R&D Managers and Engineers
Product Development Managers and Engineers
Regulatory Affairs Professionals
Quality Assurance professionals involved in design and/or manufacturing
Production Management professionals
Personnel involved in risk assessment and Risk Management activities
Dev Raheja PE, CSP, is a system safety practitioner, consultant and trainer for over 25 years. He is a Fellow and former Vice President of the System Safety Society and received its Scientific Achievement Award and Educator of the Year Award. He is the author of the text Assurance Technologies Principles and Practices: A System, Process and Safety Perspective. He has conducted System Safety training at Johnson Space Center, Kennedy Space Center, Boeing, US Navy, US Army, Lockheed Martin, and at several universities such as UCLA, George Washington University, University of Maryland, and University of Alabama. He served as Adjunct Professor at University of Maryland during 1994-99, where he taught graduate courses on system safety. He is also the member of the G-48 Committee for the Government-Industry standards and is Associate Editor of the Journal of System Safety.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Fundamentals_of_ISO