INTRODUCTION FOR ISO 14971:2019: INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES
The requirements contained in this document ISO 14971:2019 provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
This document was developed specifically for manufacturers of medical devices on the basis of established principles of risk management that have evolved over many years. This document could be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices in some jurisdictions and for suppliers and other parties involved in the medical device life cycle.
This document deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment.
Risk management is a complex subject because each stakeholder can place a different value on the acceptability of risks in relation to the anticipated benefits. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.
COURSE OBJECTIVES
- To interpret the requirements of ISO 14971:2019 Medical Devices Risk Management process.
- To be able to apply the requirements of the standard in day to day ISO 13485:2016 QMS Risk Assessment process
- To be able to demonstrate the application of the tool in classroom exercise.
WHO MUST ATTEND
Manager, Head of Dept, Quality Management Representative (QMR), Middle Management (Executives, Engineers & Supervisors) and team members of ISO13485 project.
COURSE BENEFITS
Upon completion of this program, delegates are able to:
- conduct risk assessment for all activities in their organizations
- recommend the best solutions to address significant and/or intolerable risks that exist
- use the FMEA as an assessment tool to document & record the risk management
NOTE: FULLY HRDF CLAIMABLE UNDER SBL SCHEME. HRDF REGISTERED TRAINING PROVIDER.
- MINIMUM NO OF PAX: 10-20 per class
- MODE OF DELIVERY: POWERPOINT SLIDES, GROUP DISCUSSIONS, WORKSHOPS, QUIZ.
- MEDIUM: ENGLISH & MALAY AS DEEMED NECESSARY
- DURATION: 7 HOURS CONTACT TIME PER DAY
COURSE CONTENT
Clause 5: Risk analysis
- Risk analysis process
- Intended use and identification of characteristics related to the safety
- Identification of hazards
- Estimation of the risk(s) for each hazardous situation
Clause 6: Risk Evaluation
Clause 7: Risk Control
- Risk control analysis
- Risk control implementation measures
- Residual Risk evaluation
Clause 8: Evaluation of residual risk analysis
Clause 9: Risk management review
Clause 10: Production and post production activities
- Information collection/review and action
FMEA TOOL
Risk Assessment Tool: Failure Mode Effect Analysis (FMEA):
- Identify interested parties and internal/external issues
- Identify & Prioritize Risks and rates (Severity, Detection and Occurrence)
- Severity, Detection & Occurrence Rating Scale/Matrix
- Calculate Risk Priority Number (RPN)
- Risk Prioritization Matrix
- Make improvements (action plan)
- Monitor effectiveness
Post-Training Knowledge Assessment [25 MCQ QUESTIONS GOOGLE TEST]
Course Wrap Up/Q&A
