eQMS for Medical Devices | Kintavo
DEVELOPMENT, MANUFACTURING & COMMERCIALIZATION

Medical Devices

ISO 13485 and 21 CFR Part 820 out of the box — with design controls, DHF management, and post-market surveillance.

ISO 13485 Part 820 EU MDR
Book a demo for device teams ← All industries
THE PROBLEM

Device Quality Fails at the Seams — Between Design, Production, and Post-Market.

The DHF lives in one system, complaints in another, CAPA in a spreadsheet, and risk in a document last touched at design transfer. Each is individually defensible; the seams between them are where audits go wrong — the complaint trend that never reached the risk file, the design change that never triggered a DHF update.

With FDA’s QMSR aligning Part 820 to ISO 13485, the frameworks now agree on the point: quality is one system, and the linkage is the requirement.

REGULATORY REQUIREMENTS

What ISO 13485, the QMSR, and EU MDR Require From Device Quality

ISO 13485 requires documented, linked processes: design controls (7.3), purchasing controls (7.4), nonconformance (8.3), and CAPA (8.5) feeding management review (5.6). The QMSR incorporates the standard into US law. EU MDR adds post-market surveillance with defined inputs and a PMS report auditors actually read. ISO 14971 requires the risk file to stay live against production and post-market data.

Kintavo is that linkage by construction: complaints trend into CAPA, changes carry risk assessment, and the DHF references controlled documents — one data model, one audit trail.

WHAT AUDITORS LOOK FOR
Complaint trends that never became CAPAs — the MDR/vigilance finding pattern.
Design changes without documented impact on risk files and the DHF.
Supplier controls that stop at the certificate — no performance monitoring.
CAPA effectiveness verified the day the action closed.
WHAT KINTAVO REPLACES
DHF binders and shared drives → Controlled documents with revision-linked training
Complaints in a helpdesk tool → Complaint intake feeding trending and CAPA
Risk file frozen at transfer → ISO 14971 file linked to live production data
Supplier list certified annually → Living ASL with scorecards and requalification
CAPA in a spreadsheet → Part 820.100 discipline, phase-gated and verified
CORE CAPABILITIES

From Design Control to Post-Market. One Data Model.

Document Control & DHF
Design documents under revision control with e-signature approval and training linkage.
Risk Management
ISO 14971 files that react to complaints, nonconformances, and changes — not annual reviews.
CAPA Management
Structured root cause, owned actions, effectiveness gates — the 820.100 subsystem inspectors sample first.
Supplier Quality
820.50 purchasing controls: risk-classed qualification, live ASL enforcement, scorecards.
Change Control
Design and process changes assessed across documents, risk, validation, and training before approval.
Audit Management
Internal audits per 820.22 with findings tracked to verified closure — and inspection mode for notified bodies.
WHAT IT LOOKS LIKE IN PRACTICE

Three field complaints on a connector land in a quarter. The trend rule opens a CAPA; the investigation traces to a supplier lot, which updates the supplier scorecard and the risk file in the same motion. The design change that follows carries its impact assessment, its verification evidence, and its training assignments. At the ISO 13485 surveillance audit, the auditor follows the whole chain in eleven minutes.

EVIDENCE, NOT CLAIMS

The Trail From Complaint to CAPA to Risk File — Clickable.

When a notified body auditor asks how post-market data feeds risk management, the answer is a path through linked records, each signed and dated. The seam that fails most audits is, in Kintavo, a click.

Kintavo 360-degree record view: linked documents, related records, and activity timeline on one asset
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Configured for your rules from day one.

DESIGN
Design controls & DHF
Design history files that assemble themselves from linked records instead of a folder scramble before audit.
13485
ISO 13485 out of the box
Process architecture mapped to the standard — notified-body ready without consultant translation.
POST-MARKET
Post-market surveillance
Complaints, MDRs, and vigilance feeding risk files and CAPAs in one loop.
“
"Employees praised Kintavo's intuitive design, flexibility, simplicity, and the support received from the team."
MD Anderson Cancer Center Houston, TX
MOST USED BY DEVICE TEAMS TEAMS
Document Control → Risk Management → CAPA Management → Change Control → Audit Management →
QUESTIONS & ANSWERS

Medical Devices FAQ

Does Kintavo support the FDA QMSR transition?
Yes — the QMSR incorporates ISO 13485, and Kintavo’s processes are built on that structure. Sites running Kintavo under 820 are running the 13485 process model already.
Can Kintavo hold our Design History File?
Design documents, reviews, and verification records live under document control with linkage to changes and risk — a DHF that is assembled by reference, not by binder.
How does post-market surveillance connect to CAPA?
Complaint intake feeds trending; trend rules you configure open CAPAs with the complaint history attached. EU MDR PMS inputs are queries, not projects.
Does Kintavo support EU MDR technical documentation?
The quality system records MDR draws on — complaints, trends, CAPAs, changes — are linked and exportable; your regulatory team assembles technical documentation from live data instead of chasing it.

See Kintavo configured for device teams.

Bring your real pain points. We'll show you exactly how it solves them — in your regulatory language.

Book a Personalized Demo
RELATED Who runs on Kintavo → Hoxworth case study → Compare platforms → Pricing →