After you submit the compliance check, you will receive our free advice. We aim to contact you within 5 working days. You can also directly mail or call us without using this form.
Do you have a CE certified medical device?
Do you intend to sell a class III device or an implantable medical device under the MDR?
The transfer from MDD to MDR will need investment in time & recourses. Did you analyze the impact of the MDR for your company?
The transition normally starts with a GAP analysis. Did you already do such GAP analysis on the QMS aspects, technical documentation and clinical data documentation?
Notified bodies are now in process of designation. Are you in discussion with your NB if the scope of the NB under MDR covers your device range?
Do you have experience with clinical investigations?
Do you have experience with writing clinical evaluations?
Do you have enough resources available to cover the MDR workload?
How do you want us to follow up with you?
 

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