Living Clinical Safety Cases
Hazard logs and clinical safety cases aligned to DCB0129 and DCB0160, modelled as live bowtie diagrams — with a tamper-evident audit trail your Clinical Safety Officer can sign off with confidence.
A DCB0129 Hazard Log That Actually Lives
DCB0129 and DCB0160 both require a hazard log maintained across the whole lifecycle of a health IT system — yet in practice it usually lives in a spreadsheet that drifts out of date the day after each release. In SAFOPS, every clinical hazard is a first-class object: its causes, controls, and consequences are modelled explicitly, its risk rating is computed from your matrix rather than typed in, and its full history is preserved. The hazard log stops being a document you assemble before an assessment and becomes the system of record you work in every day — and the evidence base behind the clinical safety section of a DTAC submission.
Risk Matrices Configured to Your Clinical Risk Management System
SAFOPS's risk matrices are fully configurable, so you can reproduce the 5×5 severity-by-likelihood matrix from your DCB0129/0160 clinical risk management system exactly — severity bands from Minor to Catastrophic, likelihood from Very Low to Very High, and your organisation's own acceptability thresholds. When a hazard's rating lands in a band that demands further mitigation, that requirement is carried with the hazard rather than living in a reviewer's memory. The same configurability covers ISO 14971 matrices for medical device risk management.
Evidence a Clinical Safety Officer Can Stand Behind
A Clinical Safety Case Report is a claim made under a registered clinician's professional accountability — the evidence behind it has to hold up. Every change in SAFOPS, whether made by an engineer or suggested by AI, is logged in a SHA-256 hash chain, so altering any past entry is immediately detectable. And when a system update lands, change impact analysis shows precisely which hazards, controls, and arguments are affected — so re-assessment is targeted instead of starting from scratch. Scrub back through that history with Time Machine, or freeze an approved version as a formal issue.
Software, With Safety Engineers Behind It
You don't have to adopt SAFOPS alone. Working alongside your Clinical Safety Officer, our safety engineers can do the work in the platform for you — performing the hazard assessments, building and managing the hazard log, and keeping the safety case evidence current release after release — from a one-off migration of a spreadsheet hazard log to ongoing support at every system update. Use SAFOPS as a tool, a fully managed service, or anything in between.