The Mechatronic AG is growing constantly.
Needless to say that specialist competence is required. Moreover, we attach great importance to team spirit, discipline and will to success.
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.
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.