This training is designed to enables participants to have a basic understanding on Risk Management for Medical Device.
This introductory course enables participants to have a basic understanding on Risk Management for Medical Devices.
By the end of the training, participants would be able to:
- Understand the systematic approach towards measuring risks to produce safe and effective medical devices
- Differentiate between Risk Analysis and Risk Management
- Understand and effectively develop and implement systematic application of management policies, procedure and practices to identifying, controlling, and monitoring risks to conform to the requirements of ISO 14971 and support to integration of risk management element into ISO 13485:2016 Clause 7.1 Planning of Product Realization
- Minimize / reduce errors or deficiencies that was designed into particular devices that may have been prevented by adequate design and development control
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
Managers, Engineers, Executives, Supervisors of various departments: Quality Assurance, Regulatory Affairs, Production, Engineering, Project Management, Logistics/Planning, Purchasing, and members of Risk Management Team.
- Risk Management Overview/Planning
- Risk Management Process & Plan
- Risk Analysis & Evaluation; Hazard and Harm (additional focus on PFMEA)
- Risk Estimation and Risk Evaluation
- Risk Control & Reduction (Risk Control Measures)
- Risk/Benefit Analysis
- Overall Residual Risk Evaluation
- Post Production Information
- Risk Management File & Report
- Question and answer
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.