Other Trainings
Training Synopsis
This training is designed to enables participants to have a basic understanding on Risk Management for Medical Device.
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
This introductory course enables participants to have a basic understanding on Risk Management for Medical Devices.
Learning Objective
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
Duration
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
Managers, Engineers, Executives, Supervisors of various departments: Quality Assurance, Regulatory Affairs, Production, Engineering, Project Management, Logistics/Planning, Purchasing, and members of Risk Management Team.
Course Outline
- 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
Training Certificate
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.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.