Book a QMS Gap Assessment for ISO 13485 or 21 CFR 820
Book a QMS gap assessment for ISO 13485, 21 CFR 820, or EU MDR Annex IX/XI compliance online. Compare vetted QMS consultants with instant per-assessment pricing.
✓ 3 active providers available right now
· USD 735 – 910
Why this page is different
- Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
- Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
- Charged only when accepted: You are charged only after a provider accepts your order and scope.
- Live availability: 3 active providers available right now for this service.
What you can compare here
- Total price: See live price ranges and instant pricing rules where available.
- Coverage & scope: Markets served, what is included, and what is explicitly excluded.
- SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
- Add-ons: Optional extras you can book next (shown as add-on chips).
- Onboarding time: How quickly providers can start and what you need to supply.
Compare providers (instant pricing + book)
| Provider | Estimated base price | Accept SLA | Turnaround | Start |
|---|---|---|---|---|
| Alpha Regulatory Partners | USD 800 | 24h | 3–7 days | Within 2 business days |
| Beta Compliance Group | USD 910 | 24h | 3–7 days | Within 2 business days |
| Gamma RegTech Solutions | USD 735 | 24h | 3–7 days | Within 2 business days |
Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).
What affects pricing
These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.
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standard
(Required)
iso13485|21cfr820|both
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sitesCount
(Required)
min 1
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scopeDepth
(Required)
core|standard|broad
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turnaround
(Required)
standard|rush
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desiredOutputs
(Required)
min 1
- buyerNotes (Optional)
🔍
Standards
ISO 13485 · 21 CFR 820 / QMSR
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Output
Gap report + priority action plan
⏱️
Turnaround
10–25 business days
💰
Pricing
Per scope / per standard
How it works
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1
Describe your current QMS and scopeTell us your current standard(s), device class, company size, and which QMS areas you want assessed.
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2
Compare gap assessment consultantsView fees and timelines from QMS experts who conduct structured gap assessments against your target standard.
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3
Receive your gap report and action planYour consultant delivers a scored gap assessment with prioritized corrective actions mapped to specific clause requirements.
What is a QMS gap assessment and when should you do one?
A Quality Management System (QMS) gap assessment is a structured comparison of your current quality practices and documentation against the requirements of a target standard — typically ISO 13485:2016, FDA 21 CFR 820 (Quality System Regulation / QMSR), or both. It identifies three categories of findings: (1) elements fully in place and compliant; (2) elements partially addressed but incomplete; and (3) elements entirely absent. A gap assessment is most valuable when: you are building a QMS for the first time ahead of initial certification; you are preparing for an upcoming surveillance audit and want to identify weaknesses before the auditor does; or you have received audit findings previously and want to ensure your corrective actions have actually closed the gaps.
Gap assessment vs. internal audit vs. pre-audit: what is the right tool?
These three tools serve different purposes. A gap assessment is consultative — the consultant works with your team to map current practices against requirements, often identifying documentation and process gaps simultaneously. An internal audit is a formal, evidence-based review that produces nonconformance reports and is required by ISO 13485 (clause 8.2.4) as part of your ongoing QMS. A pre-audit (or mock audit) simulates actual certification audit conditions with formal entry and exit meetings, documented findings, and NCR issuance. For a new or early-stage QMS, a gap assessment is the right starting point. For a mature QMS ahead of a certification surveillance audit, a mock audit delivers more targeted value.
What a gap assessment report should contain
A well-structured gap assessment report maps each requirement clause of your target standard to your current state, assigns a conformity status (compliant, partial, non-compliant, or not applicable), provides a root cause for each gap identified, and proposes prioritized corrective actions with estimated effort levels. The best reports include an executive summary section with a heat-map or scoring table for quick identification of the highest-risk areas, a detailed clause-by-clause findings table, and a recommended action plan with sequencing based on audit risk, compliance deadlines, and implementation dependency (e.g., document control must be in place before most other procedure records are valid).
Key areas that most often show gaps in QMS assessments
Across hundreds of QMS gap assessments, the areas that most consistently show significant gaps in medical device manufacturers — especially early-stage companies — are: CAPA process effectiveness (criteria for opening CAPAs, root cause methodology, effectiveness verification); post-market surveillance integration (complaint-to-trend analysis, feedback into design risk management); supplier management depth (supplier evaluation criteria, re-evaluation frequency, supplier performance records); and design and development controls (design review records, design verification and validation linkage to requirements). These are also the areas FDA inspectors and ISO 13485 notified body auditors scrutinize most heavily.
Frequently asked questions
- What is a QMS gap assessment?
- A gap assessment compares your current quality management system practices and documentation against the requirements of a target standard (e.g., ISO 13485, FDA 21 CFR 820/QMSR). It identifies what is in place, what is partially met, and what is missing.
- How is a gap assessment different from a full audit?
- A gap assessment is a consultative, collaborative review focused on identifying weaknesses and planning remediation. A formal audit results in a conformance decision and, for certification audits, issues nonconformances. A gap assessment is ideal before an upcoming audit.
- How long does a remote QMS gap assessment take?
- A focused remote assessment of a mid-size QMS typically takes 10–25 business days including document review, stakeholder interviews, and report preparation.
How Cruxi Bridge vets providers
- ✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
- ✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
- ✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
- ✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms
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