Hazard Analysis in the context of ISO 14971 and IEC 62366-1

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  • Is rmForge output suitable for a submission?

    Final acceptance depends on the user-manufacturer's risk management process, the design history file, and Quality Management System (QMS). rmForge does not guarantee submission acceptance. rmForge explicitly states that qualified cross functional review and approval per a QMS-based risk management process is required by the user-manufacturer. rmForge does not accept responsibility for the content of a file or submission in any form.

  • Does rmForge align with ISO 14971?

    Yes, we endeavor to align with ISO 14971. Our internal specifications are written in harmony with ISO 14971 and ISO TR 24971.

  • Does rmForge handle IEC 60601-1 Essential Performance?

    Yes for ME devices. The Essential Performance agent implements a structured preparation and assessment sequence aligned with IEC 60601-1.

  • Does rmForge handle IEC 62366-1 usability?

    rmForge tags every row as Intended Use, Misuse: Use Error, or Misuse: Abnormal Use, following IEC 62366-1, the International Electrotechnical Commission (IEC) standard for usability engineering of medical devices. Use-related hazards appear as rows in the Hazard Analysis.

  • Does rmForge handle IEC 62304 software lifecycle?

    No. IEC 62304, the International Electrotechnical Commission (IEC) standard for medical device software life cycle processes, covers software safety classification, architecture, unit verification, integration, and system testing. rmForge's Hazard Analysis does not produce an IEC 62304 file. It does apply one related rule. When a row's cause is software and its Severity is 4 or 5, rmForge sets P1, the chance the hazardous situation happens, to 5, the highest level.

  • Does rmForge handle ISO 10993 biocompatibility?

    rmForge surfaces biological and chemical hazards in the HA. A full ISO 10993-1 biological evaluation plan and testing report is out of scope.

  • Does rmForge produce a Risk Management Report?

    No.

  • Does rmForge handle post-market surveillance?

    No.

  • Can I use rmForge for veterinary or non-human devices?

    rmForge's rules are anchored to human medical devices under ISO 14971. Veterinary use is not validated. Industrial or research-only devices are out of scope for now.

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