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

We will support you in obtaining national and international approval for medical devices.

When it comes to the development of medical technology equipment in particular, processes, methods and knowledge of approval procedures need to be considered right from the start, from development to market and production readiness. All our customers, whether large corporations, small or medium-sized enterprises or start-ups, can enjoy the benefits of our expertise, especially in relation to highly complex matters involving international approval.

Consulting and approval support

We will assist you in obtaining national and international approval for medical devices and with processes such as CE, CB, 510(k), PMA, de novo and CFDA requirements. We offer expert support for your risk analysis and FMEA and will be there for you as you set up and develop your quality management system.

In addition to issues concerning approval and documentation, we are also the ideal source of advice on many other matters, such as assessing whether your project is actually realistic and what the costs will be, or if you need a second opinion on a project that is already under way.

Our team can also provide you with expert assistance in choosing a suitable OEM supplier.

  • Classification of medical devices in accordance with Annex 9 of Directive 93/42/EEC
  • Technical risk management as per DIN EN ISO 14971
  • Preparation of technical documentation in accordance with standards, as specified by Directive 93/42/EEC or e.g. for a 510(k) clearance
  • Set-up of the product file or DMR
  • Support in setting up the risk management file
  • Support in setting up and developing the quality management system
  • FMEA and risk analysis
  • Technical due diligence
  • Assistance with clinical evaluation
Here you will find additional information about our company and our services.