WE ARE MECHATRONIC
We develop and manufacture medical technology equipment for diagnosis and therapy as well as partial solutions and accessories.
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.
MedtecLIVE, Nuernberg, 21.- 23. May 2019. Visit us at our booth 529 in hall 10.
We bring your vision quickly and reliably to fruition. This is our contribution to the success of your product in the market. Years of medical industry experience, extensive expertise of processes and methodology as well as product development and manufacturing ‘Made in Germany’ – this is what Mechatronic AG stands for.
Whether you are a start-up, a medium-sized business or an enterprise: Our expertise will set up your idea – efficiently and suitable for your budget. We are your sparring partner in every phase of the product development and will quickly present necessary progress for further actions.
Using the most modern methods we develop your medical device together with you. Whether the Test Avenue® developed by Mechatronic or miniaturisation: We already know today what will be important in the future and provide the right technology.
International quality standards and usage of the Systems Modeling Language (SysML) guarantee the best results. Precision, structured project management, delivery on schedule and customer proximity characterise our work.
We give your requirements form and function. More than 40 experts in software, electronics, measurement technology and mechanics develop your product with the latest tools, from a digital 3D model to a fully functional prototype. Structured project and risk management is the basis for rapid results.
Our development methodologies do not just fulfill the technical requirements and comply with the standards – we create them.
Our range is available as complete solution or as individual service packages.
It is possible at any point to enter the process that smoothly incorporates into your procedures and work flows. We customise the individual services to meet your needs. The continuous sharing of knowledge among our experts ensures the smooth transition from product development to manufacturing.
Thus we can react quickly and professionally to product or process changes. You retain in control; we bear responsibility and deliver a product tailored perfectly to your requirements.
Mechatronic’s quality management system is certified according to DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016.
Mechatronic AG is also FDA accepted and CSA controlled.
Regulary inspected by the following organizations:
TÜV, FDA, ANVISA, UL, CSA, INMETRO
We support you in the national and international approval of medical devices and assist you in processes such as CE, CB, 510k, PMA, De Novo or in CFDA requirements. We guide you competently in your risk analysis and FMEA. Furthermore we are there for you in setting up and enhancing your quality management system.
We provide test equipment for quality assurance and batch production of modules and devices. Our internationally installed and approved modular ATE system integrates measurement technology for electrical and mechanical parameters, programming, calibration, final testing and the corresponding data management.
We handle your product well beyond development and production. Repair of equipment and components, spare parts supply and logistics, obsolete component management as well as continuous update, upgrade and redesign are all part of our service.