Conformity Assessment

Is your company EU compliant? 

Every company must run an MDR conformity assessment for each device to confirm MDR compliance or to identify potential gaps. 

A plan for mitigation of the identified gaps should be created and followed in order to ensure compliance as smooth as possible.

Is your company EU compliant? 

Every company must run an MDR conformity assessment for each device to confirm MDR compliance or to identify potential gaps. 

A plan for mitigation of the identified gaps should be created and followed in order to ensure compliance as smooth as possible.

What can we offer? 

13FOUR85 can assist you in running the MDR conformity assessment, and the output will be a fit/gap identification. In case of potential gaps, a detailed project plan for mitigation activities will be available.

When the device complies with the regulation an EU Declaration of Conformity must be created and signed.

13FOUR85 can help you every step of the way.

What can we offer? 

13FOUR85 can assist you in running the MDR conformity assessment, and the output will be a fit/gap identification. In case of potential gaps, a detailed project plan for mitigation activities will be available.

When the device complies with the regulation an EU Declaration of Conformity must be created and signed.

13FOUR85 can help you every step of the way.

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50