Services · Service
Certification & Compliance Readiness Support
Design and technical files ready for the CE/RED route.
Overview
The problem in the field. The product is finished and the market wants CE; the manufacturer doesn't know which directives apply, which tests are needed or what the technical file must contain. On the first visit to the lab the product fails on EMC emissions or RF spurious emissions; every retest costs both time and money. The technical file is scattered, there is no risk assessment, the label is wrong and it's unclear who will sign the DoC. Wireless products add RED and the BTK notification on top; importers and resellers keep asking "is it certified?".
The Elmes solution. We start with an analysis: product definition, target market, the applicable directives and harmonized standards, test plan, gaps and a budget range. Pre-compliance measurements are made in our workshop: RF power/harmonics/spurious emissions, antenna matching, EMC pre-scan. Findings are fixed in the design (filtering, grounding, layout, firmware duty cycle) and measured again. The technical file is compiled: product definition, schematic/BOM, risk assessment, test plan/reports, manual, label and a DoC draft. An accredited lab is selected, samples and documents are prepared, tests are attended and findings are closed. For Turkey, the BTK notification is prepared.
The result. You go to the lab "ready"; the technical file is a single package; the manufacturer knows what they are signing. Certificates come from the lab or notified body and the declaration from the manufacturer; Elmes manages the process.
| Criterion | Going straight to the lab | Certification consultant | Elmes |
|---|---|---|---|
| Applicable standards analysis | Partly, in the lab quote | Yes | Yes |
| Pre-compliance measurement | No (paid pre-test at the lab) | Usually no | Yes (workshop equipment) |
| Fixing findings in the design | Left to the manufacturer | Guidance | Elmes fixes and re-measures |
| Technical file compilation | Left to the manufacturer | Yes | Yes (with design knowledge) |
| Issuing certificates | Lab / notified body | No | No (preparation and management) |
Features
- RF pre-compliance measurement: output power (with ERP/EIRP calculation), harmonics and spurious emissions, band edge, SWR/antenna matching; compared against EN 300 220 limits.
- EMC pre-scan: locating emission sources with a near-field probe and a spectrum analyzer.
- Test-mode firmware: continuous carrier, modulated continuous transmission, channel selection, duty-cycle disable; mandatory for lab tests. On Elmes devices it comes ready with the SDK package.
- Fixes by the designer: findings are closed in the schematic, layout and firmware, then re-measured.
- Risk assessment support: a hazard list and mitigation table following the EN ISO 12100 / EN 61010 / EN 62368-1 approach, depending on product type.
- BTK notification: band/power conformity for short-range devices and the application file, drawing on the experience from the Wireless RS485 Modem application.
- EN 54 preparation: EN 54-25 requirements analysis for wireless fire components, building on the preparation work for the Wireless Fire Alarm System (Firesens).
- TargetConducted emissions pre-test: in-house conducted-emission pre-measurement once the equipment is complete.
- TargetTechnical file template: a standard folder structure and checklist.
- TargetFast track for module users: once the Elmes Module Series has its RED certificate, a "radio module integration" file approach for products using the module; a full radio test may not be needed (to be confirmed with the lab).
Service scope
Indicative durations and pricing depend on project scope; final figures are set in the quotation.
Values marked “Target” are design targets, next-generation values or chip-vendor data; they are updated as measurement and certification are completed.
| Scope |
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|---|---|
| Out of scope |
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| Process | Analysis and test plan → pre-compliance measurement → design fixes and re-measurement → technical file and DoC draft → lab selection and application → test attendance → closing findings and BTK notification → close-out with the manufacturer's signature. |
| Typical duration Indicative |
|
| Deliverables |
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| What we need from you |
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| Team & tools | Team: RF/hardware engineer, embedded engineer (test-mode firmware), documentation lead. Tools: spectrum analyzer, RF wattmeter, antenna analyzer, SWR meter, oscilloscope, RF channel/interference scanner; current standard texts; technical file template; list of accredited labs. |
| Pricing model Indicative |
|
| Warranty & maintenance | The technical file is delivered complete and up to date; updates for new standard versions are quoted separately. A first-time pass at the lab is not guaranteed. The manufacturer is responsible for keeping the file for 10 years; Elmes keeps a copy under contract. |
| Target commitment Target | If a product that passed our pre-test gets a lab finding, the fix man-days are discounted (as set in the contract). |
Applications
- OEM device manufacturers
- Machine control electronics
- Wireless product makers
- Elmes module users
- Lab and test equipment
- Fire and security components
- Importers (file review)
Compliance & documentation
Contract. We work under a service agreement with a statement of work (SOW); the contract with the laboratory is directly between the customer and the lab. Product design and test results are confidential (NDA); Elmes may cite the work as a reference only with permission.
Responsibility. The declaration of conformity and product liability rest with the manufacturer. Elmes does not issue certificates; it takes on the analysis, measurements, design fixes, technical file and process management. The technical file belongs to the customer; Elmes's templates and method files stay with Elmes.
Framework. In Turkey, the CE regulations (TSE / Ministry of Industry and Technology) and the BTK regulation on short-range radio devices are used as the reference.
- Out of scopeIssuing certificatesTesting is done by an accredited lab and assessment by a notified body; the manufacturer signs the declaration of conformity.
- Out of scopeAccredited measurementWorkshop measurements are reported as "pre-compliance", stating the calibration status of the equipment.
- Out of scopeATEX, MDR, SIL/PL certificationPreparation only: technical documentation and test plan.
- AvailableBTK notification — short-range devicesBand/power conformity analysis and the application file are prepared.
- TargetTracking the harmonized standards list (Official Journal of the EU)
Frequently asked questions
Do you issue the CE certificate?
No. Testing is done by an accredited laboratory and the declaration of conformity is signed by the manufacturer. Elmes handles the analysis, pre-measurements, design fixes, technical file and management of the lab process.
Our product failed at the lab; what can you do?
We re-measure the finding from the lab report in our workshop, fix it in the design (filtering, layout, firmware), verify it and get the product ready for retesting.
Which tests are required?
It depends on the product and the market; the analysis package produces the list of directives/standards and the test plan. Wireless products need RED (radio + EMC + safety), non-wireless products EMC + LVD; RoHS applies to both.
Does your pre-test replace the lab test?
No. The pre-test is for finding problems before the lab; it is not an accredited measurement and is labeled "pre-compliance" in the report.
If we use an Elmes module, do we still need a radio test?
Once the module has its RED certificate, a product that follows the integration rules may need less radio testing; this is confirmed with the lab. A RED certificate for the modules is a target. The final product's EMC and safety tests are still required.
Is BTK required for sales in Turkey?
Short-range devices must meet the regulation's band/power rules and go through a notification process; we prepare the application file.
What should the technical file contain?
Product description, schematic/BOM/layout, risk assessment, list of applied standards, test reports, user manual, label, DoC and revision record. We compile it from a template.
How long does it take and what does it cost?
End to end 2–6 months (indicative; depends on the lab's schedule). The Elmes service fee is fixed per package; lab fees are paid directly to the lab.
Can you help with medical devices or ATEX too?
Only with preparation (technical documentation, test plan). Certification is a notified-body process and is out of scope.
Let's talk about your project
Our engineering team replies within 24 hours.
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