Risk Management Training for Medical Device Professionals
Beneficial for
- Professionals involved in risk assessment and management
- QA and QC Professional
- Professionals involved in designing development and manufacturing
- Medical Device Design Engineers
- Product Managers
- Regulatory Affairs Professionals
Course Outline
Risk Management is an important and complex process that is growing in importance for medical device companies with its introduction into a number of recently published medical device standards. ISO 14971 has been written to enable its integration into existing company quality systems and provides a disciplined approach for proactive decision making based on recognised risk and the implementation of strategies to mitigate those risks. This practical, workshop based course with case studies has been designed to provide delegates with the skill (including tools and techniques) and knowledge required to understand, interpret and apply ISO 14971 as well as the ability to integrate risk management into their existing organisation and Quality Management Systems.
The course will focus specifically on the ISO 14971 requirements in relation to the development and implementation of an effective risk management lifecycle and will also incorporate the requirements of the Global Harmonization Task Force’s guidelines.
Main Points:
- Requirements for risk management
- Overview of ISO 1497 Standard
- Risk Management process
- Risk management file
- Risk management plan
- Suitable format for Risk Management report
- Risk Analysis Process
- Identification of Hazard
- Risk Evaluation – Identification of harms, hazards and hazardous situations, tools and techniques including FMEA, Fault Tree Analysis
- Risk Reduction and Control
- Estimation of Residual Risk
- Risk Report including the risk benefit analysis
- Production and Post Production requirements as part of ongoing Post Market Surveillance activities
- Relation with the other medical device standards
- Overall Risk Management throughout the product lifecycle
For more information contact info@dknsb.in or visit www.dknsb.in
