MDR/IVDR-COMPLIANCE-AS-A-SERVICE

Are you overwhelmed by the obligations of the MDR/IVDR for your devices?
We make sure that you implement them as required.

As of May 26, 2021, the new Regulation (EU) 2017/745 on medical devices (MDR), which is intended to ensure greater safety and transparency for medical devices within the European Economic Area, is ultimately considered mandatory. When it comes to IVD, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has been effective since May 26, 2022.

New medical devices or IVD applying for CE certification have to adhere to MDR or IVDR, respectively, whereas manufacturers of legacy devices must pay attention to current transition periods of the former European Directives.

In addition, there are still some national regulatory requirements the manufacturers of medical devices and IVD need to comply with.

If you as a manufacturer are facing these challenges, THE FORCE supports you in...

...analyzing where your products need to be adapted from former to new legal requirements.
...adapting the technical documentation for your medical devices accordingly or in creating new documentation.
...adapting your quality management system sustainably to all applicable standards.
...training your employees for all (new) processes and requirements.
...preparing optimally for the certification audit and conformity assessment by a Notified Body.

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