Risk Management for Medical Devices | MDV-Solve
Risk Management
Risk management is a critical process for medical devices. We assist in implementing ISO 14971:2019 compliant risk management processes throughout the product lifecycle.
Risk Management activities:
- Risk Management Plan
- Hazard Analysis
- FMEA (Design and Process)
- Risk-Benefit Analysis
- Risk Management Report
- Production and Post-Production Information
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Good Manufacturing Practice (cGMP)
Establish and implement an effective tailored cGMP system in line with requirements.
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Implementation of process validation system including IQ, OQ, and PQ qualifications.
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Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.
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