Automation for Medical Device and Diagnostics Quality
Workflow and AI automation for CAPA, complaints, nonconformances, document control and production records, designed for ISO 13485, FDA QMSR and 21 CFR Part 11 from the first step.
Workflow and AI automation for CAPA, complaints, nonconformances, document control and production records, designed for ISO 13485, FDA QMSR and 21 CFR Part 11 from the first step.
Medical device quality teams spend much of their week moving information between systems and documents, not making quality decisions.
Complaints and nonconformances arrive by email, phone and portal, and each one is logged, triaged and linked by hand.
Batch and device history records are checked line by line before release, often on paper or scanned PDFs.
Since 2 February 2026, the FDA's QMSR aligns US requirements with ISO 13485. Procedures, records and training all need to reflect it.
Qualified people make every quality decision. Automation handles the clerical work around it.
Intake from every channel, deduplication, pre-classification and linking to products and lots. The owner decides.
Routing, reminders, training triggers and first drafts of change impact assessments for the change owner to confirm.
Device history records checked for missing entries, out-of-range values and signatures, with exceptions flagged for the reviewer.
Certificates of conformance and analysis extracted and checked against specification before material is accepted.
Label content checked against master data so the printed label matches the approved record.
Evidence for FDA inspections, notified body and MDSAP audits gathered from the systems that already hold it.
The FDA's final Computer Software Assurance guidance (September 2025) supports risk-based assurance for software used in production and the quality system.
What the automation does, which quality records it touches, and its risk, documented in line with ISO 14971 thinking.
Access control, audit trails, electronic signature controls where Part 11 applies, and human review of every quality decision.
Risk-based testing and records for your quality team to review and approve, following ISO 13485 clause 4.1.6 and CSA.
Every change to a workflow, prompt or model goes through your change control process.
| Standard | What it means for automation |
|---|---|
| ISO 13485:2016 | Software used in the quality management system must be validated before use, proportionate to risk (clause 4.1.6). |
| FDA QMSR (21 CFR 820) | Effective 2 February 2026, incorporating ISO 13485 by reference. Former terms such as DHF, DMR and DHR give way to ISO 13485 records, but the content still has to exist. |
| 21 CFR Part 11 | Electronic records and signatures: secure, time-stamped audit trails, limited access and signature controls. |
| Computer Software Assurance (FDA guidance, 2025) | Risk-based approach to assuring software used in production and the quality system. |
| ISO 14971 | Risk management for medical devices, the basis for deciding how much assurance each automation needs. |
| EU MDR and IVDR | EU requirements for devices and in vitro diagnostics, including UDI, vigilance and technical documentation. |
| Data integrity (ALCOA+) | Records stay attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available. |
We don't certify compliance or replace your quality team. Your quality organization owns validation and approves release.
All regulated industries · Aerospace & Defense · Automotive
This page is general information, not regulatory, export control or legal advice.
QMSR brings ISO 13485 into US regulation, including its requirement to validate software used in the quality system proportionate to risk. FDA's Computer Software Assurance guidance describes a risk-based way to do it.
AI can pre-classify, deduplicate and summarize, which saves time. A qualified person still decides reportability, risk and the CAPA itself, and that decision is recorded.
If it creates, modifies or signs electronic records that FDA requires, generally yes. We design for audit trails, access control and signature controls from the start.
Yes. We integrate with the quality, ERP and manufacturing systems you already run rather than replacing them.
The first conversation is free, takes about an hour and covers one process end to end. You keep the map whether or not you hire us.