Comprehensive Product Compliance, Certification & Representation (EU, UK & Global)
Providing peace of mind for manufacturers, importers, and distributors of machinery, electronics, PPE, and consumer products.
Everything you need to place a product on the EU market
Directive analysis, risk assessment, technical documentation, testing coordination, and certification, delivered by one team. One point of contact, one consistent standard of work.
Compliance should not be the thing that slows your product down.
EU directives are complex and change frequently. Missing a single harmonised standard or misclassifying a product can delay launch by months. AMS Consultants handles the regulatory side so you can focus on the product.
Qualified consultants
TÜV Nord, Nemko, and CMSE® credentials, with hands-on project experience across machinery, electronics, medical devices, and PPE.
Delivered on time
Schedules are planned with buffer and every milestone has a firm date. Client reviews consistently highlight fast turnaround as the reason they came back.
Regular updates
A written update at every milestone so your team always knows what stage the project is at, what is next, and what is needed from you.
One team, start to finish
Directive analysis, risk assessment, technical file, testing coordination, Declaration of Conformity, and post-market surveillance are all handled by the same consultants.
A clear path from product idea to global market access
The same structured, evidence-led sequence runs behind every project. Acting as an integrated extension of your team, we ensure you always know what stage you are at, what comes next, and what actionable engineering decisions are needed to accelerate safe market access worldwide.
Global Scoping Strategy
A no-obligation conversation about your product, target markets, and timeline. We provide clear, honest advice to confirm the applicable international regulations and outline a realistic, optimised route to market access.
Regulatory & Standard Mapping
We identify every directive, regulation, and international standard, from EU/UK harmonised standards to US FDA/OSHA requirements, that applies to your specific product and its intended use, translating dense requirements into clear steps.
Risk Assessment & File Compilation
A defensible, peer-reviewed risk assessment and the complete technical architecture (such as EU/UK Technical Files or US DHFs) are compiled to the exact formats required by global authorities, actively reducing your compliance risk.
Testing & Global Certification
Where third-party testing, EU Notified Body, UK Approved Body, or US NRTL assessment is required, we leverage our adaptable specialist network to coordinate with accredited labs and manage the process end-to-end.
Market Launch & Ongoing Surveillance
The required legal declarations (DoC/SDoC) are drafted, global compliance marks (CE, UKCA, etc.) are applied correctly, and robust post-market surveillance (PMS) is established to keep your product compliant long-term.
What a compliance project usually looks like, end-to-end
Most CE / UKCA projects run 12–24 weeks from kick-off to signed Declaration of Conformity. Below is a realistic breakdown, plus the tangible deliverables you receive at the end.
Scoping & directive analysis
1–2 weeksConfirm applicable directives, harmonised standards, and the realistic conformity assessment route.
Risk assessment & technical file
4–8 weeksPeer-reviewed risk file and Technical Construction File compiled to the format required by EU and UK authorities.
Testing & Notified Body engagement
6–14 weeksLab coordination, EU Notified Body or UK Approved Body assessment, and resolution of any non-conformities.
Declaration & market launch
1–2 weeksFinal Declaration of Conformity drafted, marks applied, and post-market surveillance plan handed over.
Tangible deliverables
Every engagement ends with documentation your engineering, legal, and quality teams can act on immediately.
- Technical filesEU TCF, UKCA Technical File, and US DHF where applicable.
- Risk assessmentsISO 12100 / ISO 14971 hazard analyses, peer-reviewed.
- Labelling guidanceCE / UKCA marks, UDI, FCC IDs, and Prop 65 warnings.
- Declarations of ConformityEU DoC, UKCA DoC, and US FCC SDoC ready to sign.
Whatever your product category, we know the regulation
Tangible outcomes we deliver, by sector. Click through to see the specific services we typically run for each.
Trusted by manufacturers worldwide.
Clients consistently highlight fast turnaround, proactive communication, and deep directive knowledge. These are real quotes from real projects.
Great job with proactive communication and demonstrated a deep understanding of technical writing. Very pleased with Stephen's work.
Get your product compliant and on the EU market
In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.