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
Related Services
Process Validation Including Software
Implementation of process validation system including IQ, OQ, and PQ qualifications.
+ Learn MoreMDSAP Program
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a …
+ Learn MoreDesign Control Under EN ISO 13485 & 21 CFR PART 820
Establish and implement a system for design controls for various classes of medical devices.
+ Learn More