Our Certification Services
We provide practical, end‑to‑end support for EU market access: from defining the regulatory scope and standards, through testing and technical documentation,
to CE marking / EU Declaration of Conformity and long‑term compliance maintenance.
Request a compliance assessment
What We Help You Achieve
- Confirm whether CE marking applies and which EU directives/regulations are relevant
- Select the correct conformity assessment route (self‑assessment vs. Notified Body)
- Build and validate a compliant technical file (technical documentation)
- Align labeling/IFU and traceability (incl. operator details where relevant)
- Prepare for Notified Body review and respond to questions/findings
- Maintain compliance after launch (updates, post‑market activities)
Services by Stage
1) Scoping & Regulatory Strategy
- Product definition and intended use
- Applicable EU legislation mapping + harmonised standards
- Gap assessment and compliance roadmap
- Conformity assessment route & module selection
2) Evidence & Testing Strategy
- Test plan based on applicable standards
- Review of existing test reports / evidence
- Coordination with laboratories (where needed)
- Traceability: requirements → evidence
3) Technical Documentation (Technical File)
- Technical file structure and document drafting/review
- Risk management documentation (where applicable)
- Labeling and IFU review
- EU Declaration of Conformity (DoC) drafting and checks
4) Notified Body Support (If Required)
- Notified Body selection support
- Submission package preparation
- Audit readiness support
- Responses to questions and nonconformities
5) Post‑Market & Maintenance
- Post‑market planning and documentation updates
- Change impact assessment (design, suppliers, labeling)
- Ongoing compliance support
Typical Deliverables
- Regulatory scope memo (applicable EU acts + standards)
- Compliance roadmap (steps, responsibilities, timeline)
- Technical file checklist + drafted/reviewed documentation
- Draft EU Declaration of Conformity (DoC)
- Labeling/IFU review notes and required changes
- Notified Body submission pack (if applicable)
What We Need From You
- Product description and variants/SKUs
- Photos of current labeling/packaging
- User manual / IFU (current version)
- Existing test reports, certificates, or evidence (if any)
- Target markets and sales model (importer / marketplace / distributor)
FAQ
Do you always need CE marking?
No. CE applies only to products covered by EU harmonisation legislation. We help confirm applicability and scope.
When do we need a Notified Body?
It depends on the legislation and conformity assessment route/modules. We determine whether Notified Body involvement is required.
How long does certification take?
Timelines depend on product complexity, evidence readiness, testing, and Notified Body capacity (if applicable).
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