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.
Product category: Regulatory affairs, Documentation, Medical device approval
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.
Product category: Other component manufacturing, Assembly
We bring your medical product to series production
As a certified production service provider, we thereby guarantee the very highest standards of quality for our customers. We see ourselves as a full-service manufacturer for small to medium-sized batches. We are a dependable and skilled partner, producing electronic and electromechanical components as well as measuring and control instruments for diagnosis and treatment. In doing so, we implement all the principles of good manufacturing practice, or GMP, from the international standard for the production of medical products.
Mechatronic AG has years of extensive experience in product development, product optimisation and transfer to series production for medical devices that are eligible for approval on international markets. Our customer projects range from core components for a proton radiation therapy system right through to blood donation devices, blood gas monitors and spirometers. Driven by our self-professed mission and associated business model, we have spent many years developing a methodology for harnessing our customers application expertise right at the start of the project and ensuring that we incorporate it smoothly over the course of the project itself.
Our sound methods expertise means that we are not just a development company for individual areas of application, but have the capacity to successfully implement practically any project relating to controlled medical devices for our customers.
Mechatronic AG also has its own well-equipped production facility and offers additional services such as device maintenance, device repairs, automated test systems and replacement part logistics.
The accompanying documentation satisfies FDA and CE requirements. The following organizations perform regularly inspections: TÜV, FDA, ANVISA, UL, CSA, INMETRO. Mechatronic AG, certified in accordance with DIN EN ISO 9001 and DIN EN ISO 13485, is headquartered in Darmstadt, Germany.