What can we do for you? Shaping an idea into a product is a complex task, and, in the majority of cases, a rather long process. It is especially true of medical devices where the project might take long years. Independent and reliable partners could prove to be essential in these cases. We offer exactly this type of assistance to you.
In which phase of the process can we support our partners? The good news is: in almost any, from the start to the product launch and beyond. We help develop complete medical systems, individual devices and subunits, and, in specific cases, help our clients carry out the production transfer or the small batch production of their product upon request.
You have our complete support in the whole duration of the realization process of your medical device idea, however, we are capable of joining your project at any requested stage.
- Following a technological research based on your idea we formulate the concept of the product.
- Based on the concept we create the prototype of the product
- Due to available prototyping technologies we are able to iterate the concepts fast according to your needs.
- We demonstrate the operation of the prototype, involving our partners if needed.
- To ensure a solid base for further development we compile the complete documentation of the prototype
- We develop your product with respect to functionality taking producibility and ergonomical aspects also into account.
- Our experts work out the production process essential to the manufacturing of your product as well as its documentation.
- We produce the pilot lots necessary for the approval process and market introduction.
- With the help of our external partners we support you at the validation procedure needed for the approval process of your product.
- We complie the technical documentation of your product.
- The above activities will be performed within the framework of our ISO 13485 certified quality management system.
- We manufacture your product or subassembly efficiently, at high standards.
- For small- and middle series production we provide a controlled production area as well as an ISO Class 8 clean room
- After an extensive fundamental review we improve your manufacturing process and equipment for cost reduction or for other requirements.
- Due to our extensive international supplier base we provide affordable, high quality parts for manufacturing your product.
- Our firm operates according to the ISO 13485 standards.