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 The term “Risk Analysis” is no longer appropriate for medical device manufacturers and has been replaced by “Risk Management”. EN 1441 is now a withdrawn standard and ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical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 Webinar:
- 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
Course Provider
John Chapman,
