ISO 13485 + ISO 14971 Wired to Evidence, Records, and Inspection-Ready Execution.
As of Feb 2, 2026, FDA’s device quality requirements operate under QMSR (21 CFR 820 as amended) with ISO 13485:2016 incorporated by reference. We build a coherent system that ties hazards → controls → verification evidence, maps procedures + records to ISO 13485 plus FDA overlays, and operationalizes CAPA + audits + management review so you’re ready for submissions, scale, and inspection.
Clause-mapped
ISO 13485 coverage with FDA overlays clearly documented.
Risk-wired
Hazards → controls → V&V evidence stays connected.
Record-ready
Procedures backed by “show-me” objective evidence.
Inspection-able
CAPA, audits, and management review run as a cadence.
What we build
A single, consistent story across risk, requirements, verification, labeling, and quality processes—aligned to ISO 13485:2016 and supported by a defensible ISO 14971 risk file.
Right-sized QMS
Procedures, records, and governance mapped to ISO 13485 clauses—tailored to your device scope and maturity.
Risk Management File
Hazards, risk evaluation, controls, verification of controls, and residual risk justification tied to claims and labeling.
FDA overlay alignment
Clause mapping + targeted additions so your ISO-based implementation stays consistent with FDA expectations under QMSR.
Design controls + traceability
Planning, inputs/outputs, reviews, V&V, transfer, and changes—tied to risk, requirements, and objective evidence.
- Requirements → design outputs → V&V evidence alignment
- Design review packages that show decision history
- Change control that preserves traceability
CAPA, audits & management review
A running cadence that turns SOPs into a living system—ready to withstand questions during submissions and inspections.
- CAPA triggers, root cause, and effectiveness checks
- Internal audit planning + evidence expectations
- Management review inputs/outputs + actions
Core capabilities
The building blocks that make your system reviewable under QMSR: clause mapping, traceability, and a practical operating cadence.
Clause mapping + objective evidence
- ISO 13485 clause-to-SOP map with record expectations
- “Show me” checklist (procedures → records → outcomes)
- Submission support: exhibit organization and naming discipline
Traceability that holds up
- Requirements → risks → controls → V&V → labeling/IFU claims
- Control selection rationale + residual risk logic
- Verification evidence mapping (bench/EMC/biocomp/software/cyber as applicable)
Start with a fast QMSR fit check
Preparing a submission, scaling manufacturing, or expecting inspection? We’ll confirm the leanest safe lane based on device class, software/cyber scope, supplier complexity, and what artifacts already exist.
How we run engagements
A repeatable workflow that keeps artifacts consistent and avoids rework—mapped to ISO 13485 + QMSR expectations from day one.
Scope + boundaries
Confirm device scope and expectations, define “done,” and lock the clause map + evidence map + owners.
QMS backbone + risk wiring
Build/update the SOP set and connect risk artifacts to requirements, V&V, records, and change control.
CAPA + audits + management review
Implement cadence packages so the system runs after we exit—without heroics.
Inspection readiness
Evidence mapping, mock inspection prep, and remediation plan for any gaps found (procedures, records, implementation).
Typical pricing bands
Ranges depend on device complexity, software/cyber scope, supplier controls, and documentation maturity under ISO 13485 + QMSR overlays.
Early-stage Class I/II teams needing a credible baseline fast.
- ISO 13485 clause map + starter SOP set
- ISO 14971 plan + starter Risk Management File
- Design & development framework + templates
- Record templates + training basics
Submission/transfer stage teams needing a coherent, connected system.
- RMF build-out + control verification mapping
- Traceability: requirements → risk → V&V → labeling claims
- CAPA procedure + workflow + effectiveness checks
- Audit plan + first internal audit support
Revenue-stage teams or those expecting FDA / NB audits.
- Procedure + record completeness review (ISO 13485 + overlays)
- Mock inspection + remediation plan
- Management review package + evidence mapping
- Supplier controls + PMS/trending (as needed)
Note: scope expands with manufacturing complexity, supplier networks, and software/cyber requirements.
Prefer to start async?
Submit your details and we’ll respond with a scoped plan and a pricing lane recommendation based on complexity and audit/submission timing.
FAQs
Short answers about QMSR, ISO 13485/14971, and what “inspection-ready” actually means.
What changed with QMSR in 2026?
FDA’s device quality requirements now operate under QMSR (21 CFR 820 as amended), with ISO 13485:2016 incorporated by reference plus FDA overlays. Practically: expect ISO-style clause mapping, stronger emphasis on records/evidence, and implementation that can be demonstrated during inspection.
Do we need ISO 13485 certification to comply with QMSR?
No. Certification is optional. Your quality system still needs to meet the incorporated ISO 13485 requirements plus FDA overlays. We build systems that stand up in FDA inspections—certified or not.
Do we still need ISO 14971 if we’re filing a 510(k)?
Reviewers expect hazards, controls, and verification evidence to align with claims and labeling. We build a lean ISO 14971-aligned file that supports both submission expectations and ongoing maintenance.
Can you do this without locking us into an eQMS tool?
Yes. We can implement within your existing tooling and keep templates tool-agnostic. If you’re selecting an eQMS, we can define requirements and help evaluate fit.
Why are the price ranges broad?
Device complexity, software/cyber scope, supplier controls, and existing artifacts can change effort significantly. Intake lets us scope quickly and quote accurately.
What’s “inspection readiness” under QMSR?
It’s not only procedures—it’s evidence. We prepare the clause map, “show-me” record set, and team readiness so QA/R&D/Ops can demonstrate consistent implementation during inspection.