• "Understanding flow and pressure was an important prerequisite for Oxiplenish to trust LifeTec Group with the validation of our Airdrive. It paid off!"

    Jean-Marc ter Riet
    -

The quest

The process towards CE marking can be complex and challenging and requires partnering up with an experienced lab to test the product for safety and efficacy, and notified body to conduct conformity assessments against applicable Directives.

In many cases the safety and performance cannot be assessed sufficiently by only testing according to known standards requiring other solutions to match the innovative product. LifeTec Group is well known for their experience and expertise to help out, even in the most complex cases, with setting up a relevant and efficient regulatory test plan to reach the goals.

What we do

LifeTec Group holds close relationships with the notified body ánd other stakeholders to continuously improve and optimize processes leading up to CE. Their vast experience in performing research and development, and drafting the protocols needed for thorough and relevant testing will ensure a sufficient, time- and cost-efficient test plan.  With over a decade of experience in the field their large network will ensure a critical selection and matching of other partners and specialists needed.

By working with LifeTec Group as your guide to CE you will find yourself supported by a team of experienced technical and clinical specialists who speak the language and understand the timelines to deal with in getting the job done. Not only in preparing the test plan, but of course also in performing the actual tests and delivering the reports for your dossier.

Please contact Jurgen de Hart, your guide to CE Marking:

CEO
Jurgen de Hart
Call at +31 (0)40 298 93 93 or e-mail us

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