An impressive project history
With protons against eye cancer - the engineers at Mechatronic have done pioneering work in this area and developed something unique.

Read our latest success story here (in german)

The decisive impulse can save projects

With the PiCSO ® Impuls System, our customer Miracor Medical achieved a breakthrough in the treatment of heart attack patients.

Read our current success story here

Quality management


Our quality management department provides you with a capable contact for regulatory and normative issues as well as in the field of risk management.


We support and accompany you with:
  • Preparation of a risk management plan in accordance with DIN EN ISO 14971
  • Research into the applicable standards and basic regulatory conditions
  • Definition of criteria for compliance with the basic requirements in accordance with Annex 1 of Directive 93/42/EEC
  • Preparation of technical documentation in accordance with standards, as specified by Directive 93/42/EEC
  • Setting up of the product file
  • Setting up of the risk management file
  • Approval of medical devices in Europe and internationally (e.g. CE marking for medical devices, MDD, IVD, AIMD, FDA 510k or PMA, FDA de novo)

Tools:
  • FMEA 7 for medical devices (performance of FMEAs and risk analyses)
  • UKIS document management system