Failure Modes and Effects Analysis - An effective Risk Management Tool

Failure Modes and Effects Analysis - An effective Risk Management Tool is organized by Traininng.com LLC and will be held on Apr 24, 2019.

Overview
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Why should you Attend
FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices.

The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management". EN 1441 is now a withdrawn standard and ISO 14971:2000 Medical Devices- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003.

This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Areas Covered in the Session
• FMEA & FMECA
• Risk Management vs.ISO 13485:2003
• Risk Management & ISO 14971
• FDA’s Risk Management Requirements
• Design Control Risk Management
• Medical Device Directives & Risk Management

Who Will Benefit
Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities. Employees who will benefit include:

• Quality & Regulatory Professionals
• Quality System Auditors
• Manufacturing & Design Engineers
• Marketing Product Managers

Speaker Profile
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. 

Contact Info
Traininng.com LLC
Email: traininngdotcom@gmail.com
Phone: US: (510) 962-8903
Phone: Zurich: 41 - 43 434 80 33