Risk management is foundational in medical device design–not an afterthought. VSI Technologies guides engineering teams through ISO 14971-aligned processes to ensure safer devices, streamlined approvals, and robust market access.Core Principles
- Hazard Analysis: Identifying potential failures at each design phase
- Risk Evaluation: Severity and probability scoring
- Control Measures: Design, process, and labeling options
- Risk-Benefit Documentation per FDA and EU Medical Device Regulation (MDR)Architecture
VSI embeds risk traceability into PLM and ALM systems, enabling automatic updates and audit-ready reporting.Benefits
- 30% faster risk submission turnaround
- 20% fewer responsive design changes post-approval
Conclusion
Don't wait–build risk recognition into every engineering decision. VSI empowers clients to deliver safer medical devices with speed and assurance.
