From regulatory uncertainty to market readiness

Services designed by someone who spent his career on the evaluation side: testing products, reviewing files and making certification decisions.

Manufacturing a drone or UAS?

EU drone regulation 2019/945 carries conformity requirements beyond standard CE marking. Visit the dedicated UAS & Drones page.

Diagnose · Build · Maintain · Expand

The same gaps, misunderstandings, and documentation issues keep delaying market access for manufacturers. Years of testing and certifying electronic products. Now on your side.

01

Compliance Gap Assessment

02

Turnkey Technical File

03

External Compliance Manager

04

Global Market Access

01

Compliance Gap Assessment

The regulatory map before the investment

Most products that end up blocked at customs, suspended from marketplaces, or questioned by market surveillance authorities share the same root cause: no one mapped the full regulatory scope before the product shipped.

The Compliance Gap Assessment gives you a fixed-scope diagnostic with a clear picture of your product's regulatory status. Find out where the real technical risks are, and what it will cost to fix them.

The assessment covers the identification of directives (RED, CRA EMC, LVD, RoHS, Machinery Regulation, CPR...), harmonised standards, documentation review, and a review of your CRA vulnerability reporting procedure.

Every finding is prioritised by criticality. The result is a structured roadmap with corrective actions, estimated lab and certification costs, and a recommended market access strategy.

Outcomes

  • Regulatory scope: applicable legislation and harmonised standards
  • Documentary review of existing technical materials
  • CRA Article 14 reporting readiness review
  • Gap analysis with findings ranked by criticality
  • Corrective action roadmap with cost and time estimates
  • Strategy session to walk through findings

€900 Fixed fee | Delivered in 5–7 working days

Once the gaps are clear, it's time to close them.

02

Turnkey Technical File

Your technical file, from analysis to delivery.

The technical file is the record that demonstrates your product meets every applicable regulatory requirement. It is the foundation of the Declaration of Conformity, the CE marking, and the legal defence of the product if it is ever questioned.

Instead of coordinating laboratories, standards, documentation and risk analysis yourself, you work with one point of contact from start to finish. Avoid delays and costs. Provide the technical information about your product and everything else is handled end to end.

This service covers the full cycle: regulatory analysis, harmonised standard selection, test strategy design with laboratory quotes and coordination, technical file preparation, risk analysis development and post-delivery support for Notified Body questions.

Optionally, the service can include a review or development of your production control plan, whether to prepare the manufacturing line for certification audits or to fulfil the manufacturer's ongoing conformity obligations.

Outcomes

  • Test plan and lab coordination
  • Complete technical file
  • Product-specific risk analysis
  • EU Declaration of Conformity ready for signature
  • Production control plan review if requested

From €2,500, depending on product complexity.

Legislation changes, harmonised standards get revised and new product variants appear. Compliance isn't finished once the CE marking is on the product. The External Compliance Manager keeps your portfolio current without hiring in-house.

03

External Compliance Manager

A regulatory expert without the headcount

Legislation is evolving. Harmonised standards are being revised. Market surveillance has intensified. Exposure grows silently.

This is a retained service that gives electronics manufacturers and importers direct and continuous access to senior regulatory expertise, without the cost or complexity of an internal hire.

The retainer covers ongoing regulatory consultation, proactive tracking of normative changes affecting your products, regulatory review of new products and design variants, customs incidents and market surveillance response. It also covers the preparation and development of corrective action plans when certification audits of the manufacturing line result in findings.

Outcomes

  • Regulatory expert on call
  • 24-48 hour response window
  • No juniors, no account managers, no intermediaries
  • Annual strategic review of your full portfolio

From €600 / month · Scope defined by portfolio size · No minimum commitment

The Global Market Access service extends your regulatory strategy internationally without duplicating tests or documentation.

04

Global Market Access

One coordinated strategy for every target market

Most manufacturers certify market by market. New labs, a new set of tests, a new stack of documentation for each country. Enter new markets without starting compliance from scratch.

This service replaces that with a structured international compliance strategy built on your previous work. It identifies testing equivalences, certification sequencing for maximum cost efficiency, leverages the CB Scheme where applicable, and coordinates laboratories and certification bodies across regions through a single point of contact.

Markets covered: UKCA (United Kingdom), FCC and UL (United States), ISED (Canada), MIC/TELEC (Japan), RCM (Australia and New Zealand), KC Mark (South Korea), plus Middle East, India, Brazil, Mexico, and others on request.

Outcomes

The deliverable is a complete international compliance roadmap: certifications required per market, estimated costs, implementation timeline plus technical support throughout the process.

Pricing depends on the number of target markets.

Not sure where to start?

"I have a product but i am not sure what regulations apply"

Compilance gap assessment

"I know what I need but the technical file and testing are not done"

Turnkey technical file

"I already have products on the market but no one is tracking regulatory changes"

External compliance manager

"I need to sell outside Europe and I want to reuse my CE work"

Global Market Access

"My situation does not fit any of these"

Tell me about yout product and I will tell you what it needs

Looking for directive-specific guidance?

If you need to understand a specific directive and its possible conformity assessment procedures, the Regulations hub covers individual regulatory frameworks in detail.

Need something outside these services?

Every product is different, and not every project fits a fixed package. Tell me about your product — I'll tell you honestly whether it needs a full service, a smaller scope, or just an advice.