EU-MDR Compliance Check

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.