ISO 14971 Risk Analysis & FMEA for Medical Devices
This two-day interactive workshop was designed to learn basic steps of risk management as per requirements of ISO 14971 Risk Analysis and FMEA for medical devices. Get an in-depth understanding of how FMEA is managed as a process. This course is a dynamic, hands-on learning opportunity to gain practical knowledge.
At the end of the session , participanats will be able to:
- Conduct risk analysis and failure mode and effects analysis to identify hazards
- Apply risk analysis methodologies to medical devices
- Learn risk evaluation and risk control principles that affect decision making
- Identify design or process failures and opportunity for developmentImproved risk management
This course is recommended for:
- Program Managers
- Product Managers
- Quality Managers
- Design Engineers
- Manufacturing Engineers
- R&D Managers Engineers
- Quality Assurance Managers
- Management Representatives
- Design Teams
- Design Review Teams
- Project Managers
- Internal and External Auditors
Participanta should have atleast basic knowledge on:
- Product Design
- Product Development or Manufacturing
- Knowledge of basic quality assurance concepts
- Expectations of the Food and Drug Administration (FDA) and the EU in applying risk analysis to medical devices
- Risk management requirements and the purpose of ISO 14971
- The application of ISO 14971 to medical devices
- The application of risk analysis methodologies such as FMEA to medical devices
- The principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks
- Sources of information and further development
For payment and other inquiries, please contact Ms. Carla Toralballa, Sales Executive (Carla.Toralballa@tuv.com | +63 998-975-6871).
- Fees are inclusive of training materials and certificate.
- Unless specified in the course brochure, training fees subjected to a 12% VAT.
- All participants are required to pay 50% down payment before the first day of the training.
- TÜV Rheinland Philippines, Inc. reserves the right to postpone and cancel public courses.
- Unless cancelled by TÜV Rheinland Philippines, training fees are non-refundable.
- Participants with late cancellation (five days prior the training schedule) will not be refunded. Full amount of the training fee will be charged and invoiced.
- Transferability: If you are unable to attend, a substitute delegate may attend in your behalf. Please provide the name and title of the substitute delegate
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