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+31 (0)294 41 75 81

CE Mark Medical

US Market Access
US Market Access

FDA 510 Registration
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EU Market Access
EU Market Access

CE Marking of European product compliance
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Asia & China Market Access
Asia & China Market Access

CFDA Registration
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Our Services 

We assure compliance for the following products


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OUR EXPERTISE

Our expertise is based on a combination of practical and theoretical knowledge in Medical Device product safety, engineering, quality assurance, technical documentation and the use of test facilities.

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CE Marking Medical Device 

Medical Device products must be CE marked before they can be legally put into use in Europe. The  products must comply with the European CE marking Directives such as Medical Device Directive (MDD) 93/42/EEC or In-Vitro Diagnostic Medical Devices (IVDD) 98/79/EC and Active Implantable Medical Devices (AIMDD) 90/385/EC. CE Medical has expertise in all procedures required to arrive at a successful CE marking certification and offers full assistance to gain the CE Mark of your Medical Device products.

CE Medical, in partnership with Certification Experts BV, is a technical and legal certification company specialized in CE and CFDA of Medical Devices.


There are 4 easy ways to contact us!

  1. Call us: +31 (0)294 41 75 81
  2. E-mail us: info@ce-mark-medical.com
  3. Request a call back
  4. Fill in our contact form