Industries / Medtech
For ISO 13485 and FDA QMSR manufacturers
Make every CAPA investigation ten times faster, with the operator’s own evidence.
In a validated process, the difference between a closed CAPA and an open finding is often the evidence chain. Floorstack captures the operator’s intervention as objective video and audio evidence, links it to the device history record by UDI, and keeps an audit trail aligned with 21 CFR Part 11.
01
Multimodal capture
Operator video and audio as objective evidence. Captured only during defined deviation or intervention events.
02
QMSR and ISO 13485 aligned
Designed for the new FDA QMSR (effective Feb 2026) and ISO 13485:2016 expectations.
03
eDHR linkable
Each capture links to the electronic Device History Record by UDI, lot and serial.
04
Audit trail by default
21 CFR Part 11 audit trail, e signatures, access control. On every record.
Standards and frameworks
- ISO 13485:2016
- FDA QMSR (21 CFR 820, effective Feb 2026)
- 21 CFR Part 11
- EU MDR 2017/745
- ISO 14971
- MDSAP
Workflows
Five workflows we build for
CAPA
CAPA evidence capture.
Operator side video as objective evidence in corrective and preventive action. Searchable by symptom, by equipment, by UDI.
NCMR
Non conforming material investigation.
Surface past resolutions of similar non conformances. The next investigator starts with the corpus, not a blank form.
eDHR
eDHR enrichment.
Video evidence linked into the Device History Record by UDI, lot and serial. For audit and post market surveillance.
Training
GxP compliant operator validation training.
Validated training replay with traceable records of competence. Built on real, anonymized prior interventions.
Audit
Audit ready precedent retrieval.
FDA and notified body inspectors get evidence that’s structured, traceable, and retrievable on demand.
“When we get audited, the question is never whether we have an SOP. It’s whether we can prove the operator followed it on a specific lot on a specific day.”
Engage
Bring quality on site.
Two to three days on site. Shadowing five to eight expert operators during a validated process. Full NDA. Quality and regulatory walkthrough.