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A Clear Path
From Assessment to Approval
Compliance projects fail when scope is vague and requirements surface late. Ours are structured in four stages, so you know at every point what is being done, what is needed from you, and what comes next.
- A division of Liberty Management Group Ltd — established 2009
- Aurora, IL · Greater Chicago
- Submission-ready documentation
- On-time delivery
Four Stages, Clearly Defined
The stages are sequential but not rigid. Where a client already has part of the work done — a technical file that needs updating rather than writing, or a quality system that predates the standard they now need — we start from what exists and adjust the scope, rather than repeating work you have already paid for once.
1. Assess
We start by understanding the product and the market.
Most of what decides cost and timeline is settled here. We look at what the product actually is rather than what it is called — intended use, how it is powered, what it comes into contact with, who operates it — because those are what drive classification. Where a product is going to more than one market the pathways separate at this point: the same item can be low-risk in one jurisdiction and require third-party involvement in another, and knowing that at the start changes what the rest of the project looks like.
- Product, intended use and target markets reviewed
- Applicable Directives, Regulations and standards identified
- Existing documentation and systems examined
- Classification and conformity route confirmed
- Where the product sits against comparable products already on the market
2. Plan
You receive a roadmap before any work begins.
The roadmap is written before any implementation work starts, and it is specific: which documents will be produced, which tests are likely to be needed and by whom, and what we need from your team at each point. If the honest answer is that a requirement will be difficult or expensive for you to meet, it goes in the plan — that is considerably cheaper than discovering it three months in.
- Gap analysis against the applicable requirements
- The evidence and testing your file will need
- A realistic timeline mapped to your launch dates
- A clear scope so there are no surprises later
- Requirements we expect to be difficult, flagged up front rather than later
3. Implement
We do the work, with your team involved throughout.
We write documentation that describes how you actually operate, not a parallel system that has to be maintained alongside the real one. In practice that means time with the people doing the work — production, quality, engineering — and drafts that come back to us for correction rather than for a signature. Where testing is required we manage the laboratory relationship and interpret what comes back, but the technical file stays yours.
- Technical file and documentation prepared
- Management system procedures built and rolled out
- Risk management and testing guidance provided
- Staff training and internal audits delivered
- Coordination with test laboratories and interpretation of results
4. Certify
We stay with you through review and clearance.
Submissions and audits generate questions, and how quickly those are answered usually decides how long this stage takes. We draft the responses, attend the audit or the review where that helps, and stay involved after the certificate or clearance is issued. Surveillance audits, product changes and revisions to the standards you are certified against all keep the file live — the 2026 revision of ISO 9001 is a current example.
- Notified body or certification body liaison
- Audit preparation and response to findings
- FDA correspondence through to clearance
- Ongoing maintenance and surveillance support
- Support at surveillance audits and through standard revisions
What We Need From You
The projects that run to schedule have three things in common: one named person on your side who can make decisions, access to the people who do the work rather than only to their managers, and straight answers about what is currently in place. Nothing else depends on you having compliance expertise in-house — that is what you are engaging us for.
Need Help with Compliance?
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Experienced Experts
Hands-on experience in regulatory compliance and management systems.
Tailored Solutions
Solutions that fit your business, industry, and product requirements.
On-Time Delivery
Efficient and reliable service to help you meet your business deadlines.