Your Authorized Representative - "Made in Germany"

CE – marking for medical devices

You need to know how you can obtain CE-marking for your devices?
You are unsure as to which conformity assessment route would best
suit your individual requirements?
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Authorized Representative in accordance with
MDD 93/42/EEC (2007/47/EC) & IVDD 98/79/EC and others

What exactly is an Authorized Representative?
What is important for a manufacturer when choosing an Authorized Representative?
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Consultancy: EU Regulatory Affairs

Which rulings do you need to bear in mind over and above the well known medical device
Directives?
What is the status in the EU with regards to the enhancing environmental legislation?
Are your products effected?
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Benefit from additional services provided by our strategic network partners:

Identification of distributors, Professional translation services, FDA/510k approvals,
Chinese market approvals, WEEE registrations
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