Medical Devices
AMAR Reporter
AMAR-grade reporting for medical device events.
Log incidents the way the Israel Health Ministry expects: 48-hour clock, signed evidence, attested chain. No more spreadsheet panic.
The pain
A medical device event happens at 23:14 on a Friday. The Israeli AMAR clock starts the moment the clinician knew. By Monday morning the regulator wants the full report — and your team is reconstructing timestamps from email threads and shift logs.
The solution
AMAR Reporter signs the incident the second it is logged, runs the 48-hour clock against signed evidence, and produces the regulator-ready packet automatically. Your team writes the medical narrative; the system handles the chain.
How it works
4-step flow from intake to audit.
- Step 1
Capture the event
Clinician or QC engineer logs the incident; the system signs it with the device UDI, the clinician identity, and the trusted timestamp.
- Step 2
Run the 48h clock
Statutory deadlines run from the signed event time. Late steps escalate to the medical director and DPO.
- Step 3
Build the AMAR packet
Symptoms, device data, root cause, corrective action — every field signed by the person who entered it.
- Step 4
Submit with proof
Israeli Health Ministry-formatted bundle with cryptographic provenance the regulator can verify offline.
What’s included
Contract surface and the engineering you don’t have to build.
- Up to 1,000 device events / month, signed at intake
- 48-hour AMAR clock with signed escalation chain
- IEC 62304 + ISO 14971 evidence templates
- Health-Ministry export schema (DICOM identifiers preserved)
- Bilingual clinician interface (Hebrew + English)
- 99.9% availability for the reporting endpoint
Legal basis
The regulations this product is built to satisfy. Each obligation maps to a signed contract event you can hand a regulator.
- Israeli Medical Devices Law (2012) §12
- Adverse-event reports within 48 hours of clinician knowledge, with documented chain.
- IEC 62304
- Software life-cycle for medical-device software — every decision auditable.
- ISO 14971
- Risk-management file maintained continuously, not reconstructed.
Pricing
USD 5,000/month covers a single device family; multi-product manufacturers price per family. Enterprise tier supports global Health Authority exports (FDA MAUDE, EU EUDAMED).
Need a multi-site federation, a custom export schema, or a regulated-deployment partner? Email sales@growingintelligence.ai.
Sign your first event in 30 seconds.
The wizard pre-loads AMAR Reporter; you fill in your scope and sign. No credit card. No salesperson.