Device PSURs from many data streams — one narrative.
Asthra drafts EU MDR–aligned Periodic Safety Update Reports for medical devices, pulling sales volume, vigilance, PMCF, complaints, and literature into a single coherent safety and risk-benefit narrative — with every figure traced back to its source.
What you bring to the draft.
Asthra reconciles the heterogeneous post-market streams a device PSUR must integrate.
Sales & Distribution Data
Volume by geography and period. Asthra derives exposure estimates and the denominators for rates.
Vigilance & Complaints
Incident reports, complaint logs, and FSCAs — summarised, trended, and screened for signals.
PMCF Reports
Post-market clinical follow-up study outputs feeding the clinical-evidence sections.
Literature & Registries
Indication and competitor-device literature, plus registry and real-world evidence.
Risk Management File
The hazard/benefit baseline the PSUR updates — CAPAs and the current control set.
Prior PSUR
The previous reporting period. Asthra carries the baseline forward and reports the delta.
From scattered post-market data
to a defensible PSUR.
Upload & classify
Drop your sales data, vigilance logs, PMCF reports, literature, and risk file into the project. Asthra classifies and indexes each stream.
Approve the plan
Asthra proposes the device grouping, the exposure basis, and which source feeds each PMS section. Approve once.
Generate the first draft
Asthra computes exposure and complaint rates with auditable Python, drafts the safety narrative, and surfaces trend signals. Gaps flag where a stream is incomplete.
Writer review in Word
Refine the signal interpretation, regenerate an exposure table, or run the device reviewer persona over the risk-benefit conclusion. Every change is logged.
Hand off for sign-off
The draft ships with the audit ledger embedded. Every rate and signal resolves to the dataset and the code that produced it.
What changes for the post-market team.
Manual device PSUR drafting
- −Exposure and complaint rates pivoted by hand in spreadsheets
- −Vigilance, registry, and literature streams reconciled manually
- −Signal trending rebuilt each period from raw logs
- −Risk-benefit narrative re-argued against last period's baseline by memory
- −Traceability from a table cell to its source is informal
Device PSUR drafting with Asthra
- +Rates computed with deterministic, auditable Python
- +Heterogeneous streams integrated into one consistent narrative
- +Signals trended automatically and flagged for writer judgement
- +Baseline carried forward as structured state — delta reported, not re-derived
- +Every figure resolves to the dataset and the code that produced it
Pilot Asthra
on a real device PSUR.
30-day pilot. Bring one device family and a reporting period. We'll match Asthra's PSUR against your existing process — stream by stream.