Clinical trust, designed as architecture.
Safety and compliance evaluation requires product-specific documentation and checks. Request the current pack to review its scope.
Reference standards
Reference frameworks subject to evaluation
ISO 13485
Medical device quality management
IEC 62304
Medical device software lifecycle
IEC 62366-1
Usability engineering for medical devices
ISO 14971
Risk management for medical devices
GDPR Art. 35
Data Protection Impact Assessment
HIPAA
Administrative · Physical · Technical safeguards
FDA AI/ML SaMD
Software as a Medical Device guidance
Controls for documentation review
Control areas requiring verification
Human-in-the-Loop Enforcement
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
Consent Linking (HARD BLOCK)
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
Granular RBAC
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
Tamper-Evident Audit Trail
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
ISO 14971 Hazard Register
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
DPIA per P0 Module
Documentation of scope, implementation, tests and responsible review is required before compliance can be stated.
Module, risk-assessment and privacy-assessment counts require current documentation. They do not constitute certification or approval.
Enterprise · Under NDA
Request the Audit Pack
The Audit Pack bundles in a single ZIP: SDP IEC 62304, UEF IEC 62366-1, Vendor BAA Registry, cross-reference traceability matrix, and compliance data snapshots. Available only to auditors, hospitals or partners under NDA.