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Resource library
Cybersecurity evidence guides for medical device startups
Short, practical explainers for teams moving from MVP to regulated launch planning. Each guide is written to help founders and technical teams understand what evidence they may need before formal regulatory or partner review.
FDA cybersecurity readiness
Understand cyber-device expectations, premarket evidence, SBOMs, and update planning.
CE and UKCA evidence checklist
Turn intended use, software scope, and connectivity into early evidence questions.
SBOM and supplier risk
Plan component evidence, supplier posture checks, and post-market vulnerability monitoring.
Privacy evidence basics
Map data flows, sensitive data handling, access controls, and DPIA-style evidence.
Usability engineering evidence
Connect users, use scenarios, use errors, hazards, mitigations, and verification evidence.
SaMD evidence readiness checklist
Check intended use, software lifecycle, risks, cyber, privacy, usability, and verification evidence.
ISO 14971 risk traceability
Trace hazards, harms, risk controls, verification evidence, and residual risk decisions.
IEC 62304 software lifecycle evidence
Map software requirements, architecture, verification, maintenance, SOUP, and release evidence.
Medical device evidence glossary
Definitions for SaMD, DHF, GSPR, SBOM, VEX, risk controls, verification, and traceability.
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