Regulatory Context
← Return to FAQIs 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 Intended, Misuse, and Abuse category hazards and surfaces use-related risk rows.
Does rmForge handle IEC 62304 software lifecycle?
No. IEC 62304 covers software lifecycle processes (software safety classification, architecture, unit verification, integration, system testing). rmForge's HA does not produce a 62304 file. However, rmForge includes IEC 62304 requirement for Class C software to be held the maximum P1 probability of occurrence.
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.