Regulatory support for medical device development

The medical devices market is subject to complex and strict regulations. In order to be introduced onto the European market, medical devices need to obtain a CE mark. CE marking indicates that a device complies with applicable EU regulations. Depending on the type of project, the process of obtaining a CE mark can be anything from a two-month, simple process to a multi-year project. The Consonance regulatory team may assist you throughout this process no matter what type of device, hardware, or software you are developing. We will accompany you throughout the entire development project of your medical device to ensure that it is compliant with all regulatory requirements.

We provide services in obtaining a CE mark for medical devices and in the implementation of the ISO 13485 quality management system. These include:

  • implementation of the ISO 13485 in companies planning to produce medical devices
  • assistance in obtaining a CE mark for medical devices in line with Regulation (EU) 2017/745 on Medical Devices (MDR)
  • assistance in obtaining a CE mark for medical software (SaMD – software as a medical device) in line with Regulation (EU) 2017/745 on Medical Devices (MDR)
  • auditing of technical documentation for medical devices and medical applications
  • preparation of certification strategies for medical devices and systems.

If you would like to learn more about how our Regulatory Team may help you or send us a request for proposal, please contact the Consonance Sales Department at sales@consonance.tech.