FAST Quality for Medical Devices

Life-Critical Devices Deserve a Quality System That Proves It.

From device history records to complaint files, medical device regulation is a documentation discipline. FAST Quality digitizes ISO 13485 and FDA 21 CFR Part 820 workflows — DHR compilation, change control, complaint handling, CAPA and traceability — in one validated-ready platform.

ISO 13485:2016
FDA 21 CFR Part 820
Device History Records
Complaint & CAPA
Change Control
UDI Traceability
Image Slot: Medical Devices Quality Operations
ISO 13485
2016
Medical device QMS requirements supported end to end with digital records.
21 CFR
Part 820
Production and process controls, DHR and complaint files kept audit-ready.
100%
DHR Completeness
Device history records compiled automatically from digital workflows.
CAPA
Closed-Loop
Complaints and nonconformances driven to verified closure.
The Medical Devices Quality Challenge

The Problems That Keep Medical Devices Quality Teams Up at Night

Device History Records

Every batch or device needs a complete DHR proving it was made per the DMR. Compiling that from paper takes hours per lot and still misses records.

Complaint Handling & MDR

Complaints must be evaluated for reportability, investigated, and closed with CAPA — on regulatory clocks that paper processes routinely miss.

Design & Process Changes

Uncontrolled changes are among the most common FDA 483 observations. Every change needs review, approval, verification and traceable implementation.

Traceability & Recalls

When a field issue emerges, you need affected lots, components and customers identified in minutes — not a week of record archaeology.

Frequently Asked Questions

Questions from Medical Devices Quality Leaders

Yes. FAST Quality digitizes the documented processes ISO 13485 requires — document and record control, inspection and traceability records, complaint handling, CAPA, supplier controls and audit management — with revision history and approvals enforced by the system.
Yes. Because inspections, material references, instrument usage and operator identities are captured digitally at each step, the device history record assembles automatically per batch or serial number instead of being compiled manually from paper.
Complaints are logged with structured intake, evaluated for investigation and regulatory reportability, investigated with root cause tools, and closed with CAPA and effectiveness verification — with timestamps supporting regulatory timelines throughout.
Yes. Lot and serial-level traceability across materials, processes and shipments means affected product is identified in minutes when a field issue emerges — the difference between a targeted action and a broad recall.
Ready for Your Next FDA or Notified Body Audit?

Your DHRs, Complaint Files and CAPAs — Complete, Current and Retrievable

Medical device manufacturers run FAST Quality to keep records inspection-ready every day, not just audit week. Book a demo mapped to ISO 13485 and Part 820.

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