Regulatory Affairs

Whatever the solution your company is sourcing from ClearStream Technologies, our comprehensive knowledge and experience in regulatory affairs and associated areas will be an invaluable tool in your service package.

• A full complement of regulatory back up and support is offered to all our customers at each stage of the design cycle.
• Our knowledge and experience of regulatory restrictions and implications in the European and Global markets can be utilised by any of our customers at any stage in the solution supply chain.
• For design feasibility and prototype development, advice on the regulatory implications of a product type and target market will be provided as part of the package.
• Full validation service is offered, incorporating any or all parts of the CE mark submission pathway. This may include:

o Validation protocol preparation
o Testing
o Validation report completion
o Technical file compilation
o Submission for approval to our notified body, (DEKRA)


• We can offer a route for efficient placing of CE mark on contract manufactured product and therefore accelerated time to market for our customer.
• For distributors, we can provide a full support service to expedite the registration process in non-CE mark markets.


Please feel free to contact our Regulatory Affairs group for more information at ra@clearstream.ie


Please find below some ClearStream Regulatory documents. Additional information can be found on each indivdual product page or alternatively please contact us at the email above.