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

Consultation and approval support

We support and accompany you with:
  • The classification of the medical device in accordance with Annex 9 of Directive 93/42/EEC
  • The preparation of a risk management plan for your medical device in accordance with DIN EN ISO 14971
  • The preparation of technical documentation in accordance withstandards, 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)
  • Setting up and further development of your management system in accordance with ISO 13485 and/or 9001 (QM handbook, processes and procedural instructions etc.)
  • FMEA and risk analysis
  • Clinical studies/evaluations = technical due diligence

After-sales service

We also take care of providing after-sales product support for you:
  • Repair service
  • Fault diagnosis
  • Functional and system tests
  • Provision of spare parts
  • Stocking of spare parts
  • Obsolete component management
  • Logistics
  • Product maintenance
    • Update
    • Upgrade
    • Redesign