As connectivity, cloud infrastructure, and mobile platforms become central to modern healthcare, robust cybersecurity is an explicit regulatory requirement for both physical medical devices and Software as a Medical Device (SaMD) under EU MDR (GSPR 17.2 / MDCG 2019-16), FDA premarket expectations, IEC 81001-5-1, ISO 27001, and IEC 62443.
Lifecycle Medical Cybersecurity Strategy
- Threat Modeling & Security Risk Assessment: Identifying attack surfaces, data-flow vulnerabilities, and patient-safety impacts closely linked to ISO 14971 safety risk management.
- Secure Architecture & Controls: Authentication, role-based access control, encryption in transit and at rest, secure update mechanisms, and Software Bill of Materials (SBOM).
- Verification & Post-Market Vigilance: Security testing evidence for your Technical File combined with continuous vulnerability monitoring and patching procedures.
Reach out to Glaze Medical to build compliant cybersecurity into your medical product.