In the development of medical devices and Software as a Medical Device (SaMD), proactive Risk Management according to ISO 14971 is the backbone of patient safety and regulatory compliance.
Lifecycle Risk Management From Concept to Post-Market
- Early Hazard Identification: Identifying clinical, software, hardware, usability (IEC 62366-1), and cybersecurity hazards from initial architecture onward.
- Risk Evaluation & Prioritization: Assessing severity and probability of harm to focus engineering effort where clinical impact is greatest.
- Verified Risk Control Measures: Prioritizing inherent safety by design, protective measures, and clear safety information—with full traceability in your Technical File.
- Continuous Post-Market Alignment: Feeding real-world Post-Market Surveillance (PMS) data directly back into the Risk Management File.
Contact Glaze Medical to strengthen your ISO 14971 risk management processes.