Assessments
AI-Assisted QMS Gap Assessment
Find out where your quality system stands without spending weeks digging through scattered documents. You upload what you already have, an AI-assisted first pass maps it against QMSR and ISO 13485, and a QMS advisor reviews every result before it reaches you.
What You Receive
- 01Consultant-Reviewed Findings
- 02Prioritized Action Plan
- 03Findings Readout
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
A gap assessment answers a narrow, practical question: does your documented quality system cover what the regulations require, and where it doesn't, what is missing? We run it against FDA's Quality Management System Regulation (21 CFR Part 820), which took effect February 2, 2026 and incorporates ISO 13485:2016 by reference, including the FDA-specific additions in 820.35 for records and 820.45 for labeling and packaging controls. Firms that hold or are pursuing ISO 13485 certification get the same mapping read against the standard itself.
You don't migrate anything. Upload your procedures, work instructions, forms and records in whatever format they live in today, including exports from the eQMS you already use. The platform keeps the original files, fingerprints each one and flags duplicates, so the assessment reflects the documents you actually control rather than a cleaned-up copy.
The AI-assisted first pass does the reading: it locates where each requirement is addressed and where coverage looks missing or thin. Then an advisor reviews every result, discards what doesn't hold up, and decides severity and gap type. What you receive is advisor-reviewed findings, each tied to its source document and location, and a prioritized action plan your team can work from.
When You Need It
- You want an honest baseline before committing budget to remediation or a larger readiness project.
- Your procedures were written for the old Quality System Regulation and you haven't confirmed they hold up under QMSR.
- A new head of quality has inherited a document set and needs to know what is actually in it.
- Documents are spread across shared drives, an older eQMS and paper binders, and nobody has mapped them end to end.
- You're preparing for ISO 13485 certification, or adding FDA requirements to an existing ISO 13485 system.
- An acquisition or new product line has brought a second set of procedures into the business.
What We Do
- 01
Scope the Assessment
We agree which regulations and standards apply, which sites and product families are in scope, and whether the review stays at the procedure level or includes a light records sample. Scope varies depending on your device and classification.
- 02
Upload Your Existing Documents
Your team uploads the quality documents you already have to a private document library. Originals are preserved with a SHA-256 fingerprint per file, and duplicate files are flagged so they don't distort the results.
- 03
Run the AI-Assisted First Pass
The first pass maps each document against QMSR and ISO 13485 requirements and proposes candidate gaps, each with the passage (or the absence) that supports it. Nothing from this pass goes to you unreviewed.
- 04
Review Every Result
A QMS advisor reads each proposed finding against its source, confirms or rejects it, assigns severity and gap type, and adds what only a person reading the whole system would catch, such as two procedures that contradict each other.
- 05
Prioritize and Walk Through the Findings
We sort findings by severity, draft the action plan with suggested owners and evidence requirements, and walk your team through the results so the plan reflects how your organization actually works.
Deliverables
Consultant-Reviewed Findings
Each finding states the requirement, what we found, the source document and location, a severity and a gap type: missing procedure, procedure inadequate, no evidence, insufficient evidence, inconsistency or training gap.
Prioritized Action Plan
Actions sorted by severity, with owners, due dates and a 'what to submit' checklist describing the evidence that closes each one.
Findings Readout
A working session in which the advisor explains the significant findings, the reasoning behind each severity call, and what to tackle first.
How the Platform Helps
Document Library Without Migration
Upload files as they are. Originals stay intact, each carries a SHA-256 fingerprint, and duplicates are flagged.
Findings That Show Their Sources
Every finding points to the document and location it came from, so your team can check the reasoning instead of taking it on trust.
Evidence Review on Each Action
Owners submit evidence against each action, and the advisor accepts it or requests a revision with a note. A resubmission has to say what changed.
Immutable Activity History
Every upload, review decision and status change is recorded, giving you a traceable account of how each gap was closed.
Audits and Inspections It Prepares You For
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Certification Audit (Stage 1 and Stage 2)
The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification.
FDA BIMO (Clinical Investigation) Inspection
FDA inspection of a clinical investigation's sponsor, monitors, investigators or IRB under 21 CFR Part 812.
Standards and Regulations in Scope
Questions About This Service
Do we have to move our documents into a new system?
No. You upload the files you already have, in their current format, including exports from other eQMS tools. The originals are preserved, and your existing system stays your system of record.
Does the AI decide what counts as a gap?
No. The AI-assisted first pass proposes candidate findings and points to the source. An advisor reviews every result, rejects what doesn't hold up and makes the severity call, and nothing reaches you without that review.
Which requirements do you assess against?
By default, QMSR (21 CFR Part 820), which incorporates ISO 13485:2016 by reference, along with FDA-specific additions such as 820.35 and 820.45. We can also read against ISO 13485 for certification purposes and add other regulations or standards depending on your device, classification and markets.
How is this different from a full audit readiness assessment?
A gap assessment looks mainly at your documented system: whether procedures exist and cover the requirements. A full audit readiness assessment adds records sampling, evidence tracing and interviews with process owners, aimed at a specific upcoming audit. Many firms start here and move to readiness work once the major gaps are closed.
Can a gap assessment predict an inspection outcome?
No. Inspection outcomes are decided by FDA, and certification decisions by your certification body. The assessment gives you a reviewed, prioritized view of where your documented system falls short, so you can fix the most significant gaps first.
How is the engagement priced?
Engagements are scoped after an assessment call. The size of your document set, the number of sites and the requirements in scope all change the work involved.
Request an Assessment
Discuss AI-Assisted QMS Gap Assessment With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
