CE & FDA
Achieving CE Mark & FDA approval for your Medical Device
At Arrotek Medical under our ISO 13485:2003 accredited quality system we can compile and submit for the regulatory approval of your medical device.
With our knowledge of materials we will work with the notified body to quickly identify requirements from biocompatibility testing through to sterilization validation in order to shorten your medical device time to market.
Our past experiences of authoring technical files and design dossiers for application can be applied to your medical product. The knowledge of USP Class IV, Sterilisation, and testing requirements all lead to a quick and successful submission.
We also assist companies looking for advice on submitting for regulatory approval. Necessary information and testing procedures can be authored specific to your needs.