Quality Risk Management and ISO 14971 Medical Devices
Training Topic
Quality Risk Management and ISO 14971 – Medical Devices
Duration
1 Day
Course Overview
One day course on ISO 14971. The course covers the regulations governing risk management for medical devices and the practical implementation of risk management from design through manufacture, distribution and use, through to post market feedback.
Topics Covered
- Understanding the need for Risk Management
- ISO14971 – detailed analysis of the requirements of the standard
- Understanding the implications of the various revisions of ISO 14971
- Understanding the requirement to characterize medical devices
- Identifying possible hazards
- Estimating the associated risk – removing subjectivity
- Review & reduction of risk
- Risk Management Techniques Hazards – FMECA, Fault Tree Analysis, HAZOP and Preliminary Hazard Analysis
- How to apply Risk Management to the Product Lifecycle
- How to apply Risk Management to all aspects of Quality and Production.
Whom To Attend
- Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Management representatives
- Internal auditors
- Consultant
Learning Objectives
- State the differences between the various revisions of ISO 14971 and the implications that these have for the manufacture of medical devices.
- Interpret the regulations pertaining to Risk Management and ISO 14971 in particular.
- Identify and quantify risks associated with medical devices.
- Decide on the acceptability of those risks.
- Re-evaluate risks following corrective action.
- Apply various risk assessment techniques such as FMECA, Fault Tree Analysis and HAZOP.
Certificate
Upon completion of the course you will receive an SafeWorthy ISO 14971 participant Certificate
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