Product compliance

CE Marking

CE Marking technical file support

The manufacturer's declaration that a product meets EU directives, backed by a technical file.

Typical timeline
Typically 2 to 4 months depending on testing.
What you end up with
A technical file and Declaration of Conformity that survive a customs or market surveillance query.
Who it applies to

Is this your situation?

Exporters shipping regulated products into the European Union.

01Exporters shipping regulated products into the EU
02Machinery, electrical and medical device manufacturers
03Distributors taking on manufacturer obligations
How we help

What we actually deliver

Directive and harmonised-standard identification, technical file assembly, and Declaration of Conformity drafting.

▪Directive and harmonised standard identification
▪Risk assessment and test evidence review
▪Technical file assembly and user documentation
▪Declaration of Conformity drafting
How a project runs →
Often held together

Other product compliance work

Product compliance
ISO 13485
Medical Devices Quality Management System