Know where you stand
Gap analysis: know exactly where you stand, in under a week.
A full review of your ISO 13485 and MDR compliance, led by our experts with the platform as its engine, and delivered as a gap matrix and a prioritised roadmap.
Initial scoping is free, with no commitment. Fixed-price services, never billed by the hour.
What you get
- Platform-powered documentary analysis of your QMS and files
- Interviews with your teams
- Gap matrix by requirement
- Prioritised roadmap
Good to know
- Delivered in less than a week
- Variant: impact analysis of a new regulatory requirement on your product portfolio
Ideal if: you do not know exactly where you stand before an audit, a submission or a new project, and you want a reliable roadmap within days.
Three situations where a gap analysis becomes urgent
An audit is coming and you are flying blind
Initial certification, surveillance audit, Notified Body audit: you know there are gaps, but not which ones, or which to tackle first. Every week spent looking for them is a week lost fixing them.
A new requirement lands on your portfolio
A standard is revised, new MDCG guidance is published, a framework changes. The real question is not “what has changed?” but “what does it change for my own products?”
You are taking over a system you did not build
An acquisition, a departing quality manager, an inherited project: the system exists, but nobody knows what it is really worth any more.
Gap analysis or internal audit? The difference matters.
The two are often confused, and the choice has consequences.
An internal audit is a neutral compliance exercise. It is required by ISO 13485 clause 8.2.4, it follows a formal audit plan, and the auditor observes without advising. Its deliverable is an audit report and an action plan.
A gap analysis is an action-driven exercise. It compares your actual situation with the applicable requirements, over a scope you choose, and it is geared towards decisions: we tell you what is missing, what it will take to close the gap, and in which order to proceed.
In other words, an internal audit meets a normative obligation, whereas a gap analysis answers a management question.
See the ISO 13485 internal audit serviceOne week, not six
A traditional gap analysis spends most of its time reading. A consultant opens your procedures, records and files, and searches manually for what is missing. That is why it takes several weeks and why the scope is often reduced to a sample.
We reverse the order. The platform analyses your entire document base and surfaces gaps, inconsistencies and missing items. Our experts start from that output to do what a machine cannot: judge real criticality, set priorities, and test the documents against day-to-day practice during interviews.
The result is an exhaustive scope where standard practice settles for a sample, in a shorter timeframe.
Frequently asked questions
An internal audit meets a normative obligation, ISO 13485 clause 8.2.4: it is neutral and formal, and the auditor observes without advising. A gap analysis is a management exercise: a scope you choose, action-oriented, with recommendations and priorities. The two are complementary, but one cannot replace the other.
Your choice: your quality management system against ISO 13485, your technical files against the MDR or IVDR, or both. The scope is confirmed during the free scoping session, based on your deadline and the class of your devices.
Yes, because the document analysis is platform-powered. The short timeframe runs from the moment your documents are made available and the interviews have taken place. If your document base is particularly large or scattered, we tell you during scoping rather than halfway through the engagement.
No. The platform connects to your existing environment (SharePoint, Google Drive, OneDrive, TraceX) and reads your documents where they are, in their current format. No migration, no prior reorganisation.
One row per applicable requirement, with the status observed, the evidence examined or its absence, the criticality and the recommended action. It is designed to be dropped straight into your action plan.
Know where you stand before committing to anything
Tell us about your situation and your deadline. Scoping is free, and we will tell you frankly whether a gap analysis is the right place to start.