Home
Market Access
Services
Expertise
Knowledge center
Events & Training
Careers
About us
English
Deutsch
Français
中文
contact
Search
EU-MDR Compliance Check
Home
Market Access
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.
Name:
Email address:
Phone number
Do you have a CE certified medical device?
Class I
Class I S/M
Class II
Class III
No
Do you intend to sell a class III device or an implantable medical device under the MDR?
Yes
No
N/A
The transfer from MDD to MDR will need investment in time & recourses. Did you analyze the impact of the MDR for your company?
Yes
No
N/A
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?
Yes
No
N/A
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?
Yes
No
N/A
Do you have experience with clinical investigations?
Yes
No
N/A
Do you have experience with writing clinical evaluations?
Yes
No
N/A
Do you have enough resources available to cover the MDR workload?
Yes
No
N/A
I give my consent that Qserve may contact me via email or phone for information.
How do you want us to follow up with you?
E-mail
Phone
Subscribe to our newsletter
I have read and accept the terms & conditions
Terms & Conditions
How can we help you?
Contact us