Risk Management for Medical Devices ISO 14971
Details
- Overview
- General Requirements for Risk Management
- Risk Analysis
- Risk Management Techniques
- Characteristics related to Safety of Medical Device
- Identify of Hazards
- Estimation of Risks
- Risk Evaluation
- Risk Control
- Evaluation of Residual Risk
- Risk Management Report
- Production & Post Production Information
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A good system assures the consistency of the resulting products and services. We customize, adopt and integrate international recognized standards based Management Systems into the existing operating model and organizational context of our clients.
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Products related regulatory has becoming the new challenge for placing a product in the global market. We provide valuable supports for organizations to compliance with the essential safety and performance requirements for the intended uses of their products.