Documentation & Compliance Consulting
Regulatory Consulting
Direct guidance on which EU directives, regulations, and standards apply to your product.
Overview
What this service is
Most EU compliance problems start before anyone runs a test — they start with the wrong directive scoping. Apply the wrong directive and you commission the wrong tests, draft the wrong DoC, and discover the mistake the week before launch.
Regulatory consulting is the conversation that prevents that. We classify your product, map the directives and harmonised standards that apply, identify whether a Notified Body has to be involved, and put it all in a written advisory memo you can hand to your engineering and legal teams.
Scope
What's included
- Product classification and applicable scope analysis
- Mapping of mandatory directives and harmonised standards (with editions)
- Conformity assessment route recommendation
- Notified Body involvement guidance, where required
- Written advisory memo and follow-up Q&A
Deliverables
What you receive
Why it matters
The cost of skipping it
Wrong directive scoping at the start cascades into the wrong tests, wrong documentation, and a failed launch. Get scoping right once and the rest of the project follows.
Who it's for
Typical clients
Product managers and engineering leads beginning a new project, importers evaluating whether to take on a product line, and teams adapting an existing product to a new market.
Process
How we work
- 01IntakeBrief call to scope the product, the market, and the documentation that already exists.
- 02AnalysisGap assessment against the applicable EU directives and harmonised standards.
- 03DeliveryFinished file, report, or test results — with a walkthrough call for your team.
- 04Follow-upCorrections and support during external audits or market surveillance.
FAQ
Common questions
Not sure where to start?
Book a 15-minute intro call to discuss your compliance needs.