Medical Devices

In the medical device industry we are working together with our partner company QUNIQUE GmbH. Here, we use current, adjusted processes, which we will align with your company, in order that you can meet the requirements of the EU regulation for medical devices 2017/745 (Regulation on medical devices, MDR), as well the new EU regulation for in-vitro diagnostic medical devices (Regulation on in-vitro diagnostic medical devices, IVDR). These two are replacing the old EU regulation for active implantable medical devices 90/385/EWG (AIMD), medical devices 93/42/EWG (MDD) and in-vitro diagnostic medical devices 98/79/EG (IVDD).

Update now your processes in your company and make it fit, in order to keep the market access for your products. Take the chance and prepare your company and everything necessary for your products.

We offer you trainings, execute gap assessments and radiograph your quality assurance, if they are really ready and show you, what is really critical and essential to survive the new MDR.

  • Audits
  • Compliance Management
  • In-vitro-Diagnostics IVDR
  • ISO 13485
  • Medical Device Regulation MDR
  • Quality Management
  • Technical Documentation
  • Trainings