Risk Management Saves Time & Money
We can help you meet FDA and EU risk management requirements and follow an industry-recognized software development lifecycle (SDLC).
- Compliant with the ISO 14971, IEC 60601, and IEC 62304
- Follow an industry-recognized software development lifecycle (SDLC)
- Manage risk in every medical device lifecycle
Free Project Analysis
Let us show you how to move your idea from concept to prototype with a free customized analysis.
Medical Device Risk Management Best Practices
Risk Evaluation
We’ll help evaluate the risk profile of your device/project.
Risk Mitigation
We can help you develop and implement a remediation plan to mitigate as much risk as possible.
Residual Risk Analysis
We’ll continually circle back to ensure that your risk management needs and responsibilities are being met.
