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FOR MEDICAL DEVICE TEAMS

Automate ISO 13485 + FDA QMSR audits.
From your existing DHF and QMS.

Aligntra reads your design history files, SOPs, work instructions, CAPA logs, and risk files — and tells you, requirement by requirement, where you stand against every standard a medical device team touches. Your first audit in 30 minutes.

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ISO 13485 · FDA QMSR · EU MDR · MDSAP · ISO 14971 ENCRYPTED AT REST + IN TRANSIT NO TRAINING ON CUSTOMER DATA
finding #4923 · run 11.8s MAJOR NC
ISO 14971:2019 · §10.1 · POST-PRODUCTION INFORMATION

Production / post-production data not feeding back into the risk file.

Your CAPA system collects field complaints, but they don't update the risk evaluations they actually contradict.

Source clause
"ISO 14971 §10.1 requires the manufacturer to establish a system to actively collect and review information about the medical device in the production and post-production phases, then evaluate whether that information could affect the previous risk management assessments."
AI reasoning

SOP-CAPA-002 Rev 04 documents complaint intake and CAPA initiation. RM-PLAN-001 Rev 03 (risk management plan) defines the residual-risk thresholds. But no procedure links the two. Three CAPAs from the last 18 months reference field failure modes that, on review, would change the residual-risk acceptability for hazard H-12 (occlusion during use) — but the risk file has not been updated since Rev 03 (2024-08-12).

Related clauses: ISO 13485 §8.2.1 (feedback) · EU MDR Annex I §3 (risk management) — the same evidence is cited independently under each
EVERY CLAUSE, CITED
Industry MEDICAL DEVICES
Standards live 5 / 6
Audit run time 30 MIN
Coverage 100% · NO SAMPLING
Status ● ACTIVE

If you've been through a Notified Body audit, you already know the work.

RUN IN PROGRESS aud-26q1-13485 · 64% complete
30 / 47 docs · 17 min remaining
Live verdicts feed
§7.6 Control of monitoring and measuring equipment SOP-CAL-004 Rev 02 ● Observation now
§7.5.6 Validation of processes for production SOP-PV-001 Rev 03 ● Compliant 4s ago
§7.5.8 Identification SOP-TR-002 Rev 04 ● Compliant 11s ago
§7.4.3 Verification of purchased product SOP-PUR-002 Rev 03 ● Compliant 24s ago
§7.3.7 Design and development validation SOP-CHG-002 Rev 02 ● Major NC 38s ago
§7.3.5 Design and development review SOP-DC-007 Rev 03 ● Compliant 52s ago
§7.3.3 Design and development inputs SOP-DC-007 Rev 03 ● Compliant 1m 4s ago
WHAT YOU GET BACK

Built for the way medical device QA actually works.

SOP X-RAY SOP-DC-007 Rev 03 · 28 pp
Page
Clause
Requirement
Status
p. 4
§7.3.2
Design planning
OK
p. 6
§7.3.3
Design inputs
OK
p. 9
§7.3.4
Design outputs
OK
p. 12
§7.3.5
Design review
OK
p. 14
§7.3.6
Design verification
Partial
p. 17
§7.3.7
Design validation
Partial
p. 21
§7.3.8
Design transfer
NC
Weeks → hours
Audit prep that used to take six weeks runs in under an hour.
Drop your controlled documents — or connect Google Drive. Every document parsed page-by-page, indexed against the standard.
DHF + QMS
Design history files and quality system, read together.
DHF deliverables and QMS procedures analyzed in the same audit — every finding cites the exact document and paragraph.
ISO 14971 native
Risk file alignment, not just procedure alignment.
Risk management plans, hazard analyses, and residual-risk evaluations analyzed as documents against ISO 14971 — clause by clause.
5 standards · 1 QMS
ISO 13485, FDA QMSR, MDR, MDSAP, ISO 14971 — one document set.
Run the same QMS against any of the five. FDA QMSR coverage comes through ISO 13485 directly — the regulation incorporates it.
STANDARDS · MEDICAL DEVICES

Every standard a medical device team touches.

All requirements indexed from source text — the same document set runs against any standard you license.

ISO 13485:2016
Medical devices — Quality management systems
280
LIVE
FDA QMSR · 21 CFR 820
FDA Quality Management System Regulation (effective Feb 2026)
290
LIVE
EU MDR 2017/745
Medical Device Regulation — making available, GSPRs, post-market
431
LIVE
MDSAP
Medical Device Single Audit Program (AU, BR, CA, JP, US)
90
LIVE
ISO 14971:2019
Application of risk management to medical devices
141
LIVE
IEC 62366-1
Usability engineering for medical devices
~110
Q3
1,232 clauses indexed across the 5 live standards.
AUDIT YOUR SUPPLIERS

Run the same engine on a supplier's QMS.

A questionnaire tells you what a supplier says about itself. Point Aligntra at their SOPs and records and it audits them against the same standard — clause by clause, gaps cited to their procedures — before you sign. The week of reading you don't have time to do, done in 30 minutes. No sampling.

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See an audit run in 30 minutes. Use your DHF, or one of ours.

You don't upload a confidential design history file to a vendor on the first call — we know. Bring a folder of your own procedures if you're ready, or we'll run a live audit on a published example medical-device QMS we maintain. By the end you'll know if this works for what you actually do.

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