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AI SaMD technical conformity assessment roadmap

Consulting

Service Description

Applicable requirements for AI-based SaMD are identified, including MDR classification (Class I, IIa, IIb, III), IEC 62304, ISO 14971, IEC 62366, and the EU AI Act. A structured gap assessment is then performed across intended purpose, software documentation, risk management, usability, and clinical evaluation. Findings inform a tailored, step-by-step documentation roadmap targeting Class IIa. Recommendations on technical aspects including accuracy, robustness, validation, and end-to-end traceability from requirements to risks to tests, establishing a sound basis for the technical file.

Keywords: Device classification intended purpose SaMD EU MDR EU AI Act IEC 62304 ISO 14971 IEC 62366 software documentation risk management usability clinical evaluation
Offerings: Technological Solutions & Documentation Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
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Provider & Contact

Provider Organisation Multitel (MULTITEL)
Provider Country Belgium
Organisation Website https://www.multitel.be/

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Operational Details

Service Inputs Requests introduced by the SMEs
Service Outputs A structured gap assessment; A step-by-step documentation roadmap targeting Class IIa; Recommendations on technical aspects including accuracy, robustness, validation, and end-to-end traceability.
Dependencies & Restrictions MDR AI Act
Certification Support
  • AI Act
  • MDR 2017/745
Service Standards
  • IEC 62304
  • IEC 62366-1
  • ISO 14971