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We helped a start-up company prove conformance to the relevant EU Directives and apply the CE mark to his product in a way that could be applied to other products in the future.
The Cambridge-based company had developed an innovative new telecommunications product for the European market.
The design was highly advanced, and the company had selected a manufacturer but had little experience of regulatory approvals for this type of equipment.
Primilis was asked to help the company obtain the necessary regulatory approvals and to explain the required processes so the client could apply them for itself in the future.
The equipment was to be sold in Europe, so was covered by the ‘R&TTE Directive’ which includes specific requirements for product safety and Electro-Magnetic Compatibility (EMC).
We selected, than helped the client to use, an EMC test house that conducted testing to the Directive.
We conducted our own pre-assessment of the product to the Safety standard and identified some problems and risks. We recommended that some design changes be made and third-party testing done to prove the problems had been resolved.
We selected a test house that specialised in safety approvals, and worked with them and the client to undertake the detailed testing.
After the tests had been completed and passed we helped the client to collate all his technical information into the necessary ‘Technical Construction File’, and then to self-declare the product as meeting EU requirements via a Declaration of Conformity.
As a result of our work the client was able to rapidly ensure conformance to the relevant EU Directives and apply the CE mark to the product, which then allowed it to sell the product in Europe.
Our client’s staff also gained an understanding of the processes and the test houses that could help, which they were subsequently able to apply to other products.
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|Quality Management - ISO 9001|
|Assembly and test centre|