§ 04 · The regulated position
Built to the standard.
Every regulated and audited domain works the same way. We build the software to the standard that applies, under your quality system. Medical device or financial system, the position is the same.
Medical devices are the sharpest and most nameable proof: we build to IEC 62304 and IEC 62366-1, under your ISO 13485 quality system, our software risk analysis feeding your ISO 14971 file. ResMed is the proof, with Fire1 the connected-device depth behind it. Here is how it maps to delivery.
Standard
What we do in delivery
The artefact we produce
What your QMS owns
IEC 62304
Risk-based software lifecycle, versioned and traceable
Design records, traceability, test evidence
Release authority, the QMS itself
IEC 62366-1
Usability engineering worked into the software lifecycle
Use-specification and use-related risk inputs, evidence for your usability file
The usability engineering file itself
ISO 13485
Work to your controlled processes and your regulatory partner's
Controlled documents, inputs to your design history file
The quality system itself and the regulatory process
ISO 14971
Software risk analysis feeding your risk file
Hazard and mitigation records
The risk management file
IEC 62304
What we do in delivery
Risk-based software lifecycle, versioned and traceable
The artefact we produce
Design records, traceability, test evidence
What your QMS owns
Release authority, the QMS itself
IEC 62366-1
What we do in delivery
Usability engineering worked into the software lifecycle
The artefact we produce
Use-specification and use-related risk inputs, evidence for your usability file
What your QMS owns
The usability engineering file itself
ISO 13485
What we do in delivery
Work to your controlled processes and your regulatory partner's
The artefact we produce
Controlled documents, inputs to your design history file
What your QMS owns
The quality system itself and the regulatory process
ISO 14971
What we do in delivery
Software risk analysis feeding your risk file
The artefact we produce
Hazard and mitigation records
What your QMS owns
The risk management file
The same model holds beyond medical devices. In finance, Sage acquired the accounting software we built and kept us on. Our heavier regulated-financial work sits under partner agreements we cannot show. We build to the standard that applies, under your quality system.