Quality
ISO 14971 Medical Device Risk Management
ISO 14971 establishes the risk-management process for medical devices throughout the product lifecycle. Viltis helps organizations build practical risk files, integrate risk into design and production…
The client situation
- Launching new device programs
- Remediating incomplete risk files
- Software or IVD risk documentation gaps
- Preparing technical documentation for MDR/IVDR
How Viltis helps
Structured support, end to end
01
Step 1
Risk management planning
02
Step 2
Hazard analysis and FMEA support
03
Step 3
Benefit-risk documentation
04
Step 4
Production and post-production risk inputs
ISO 14971 establishes the risk-management process for medical devices throughout the product lifecycle. Viltis helps organizations build practical risk files, integrate risk into design and production, and maintain post-production monitoring.
Typical deliverables
What engagement can produce
Risk management plans
Risk analyses and risk control evidence maps
Benefit-risk summaries
FAQ
Common questions
Does this replace design controls?
No - risk management intersects design controls and other QMS processes. Viltis often supports both in parallel.
Related proof
Biologics CMC PIP
CMC and quality oversight for a Phase III monoclonal antibody program at a CMO.
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