Micro and small enterprises have the option to outsource the function of the person responsible for regulatory compliance.
THE FORCE is ready to take on this position for you.

Both the MDR and IVDR require manufacturers and authorized representatives to have, within their organization, a person responsible for regulatory compliance (PRRC) at their disposal at all times.

However, for micro and small enterprises, both regulations emphasize the possibility to outsource this activity. Our team can be permanently and continuously available as required as well as provide competent and qualified assistance with this task.

In this function, we follow the responsibilities outlined by the EU MDR/IVDR and ensure that:

...the conformity of medical devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
...the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
...the post-market surveillance and reporting obligations are fulfilled in accordance with MDR/IVDR. case of investigational devices, and devices for performance studies intended to be used in the context of interventional clinical performance studies (or other performance studies), a statement of compliance with the general safety and performance requirements is issued.

Reach out

for us to support you with the required person responsible for regulatory compliance.