The development of medical technology products is particularly characterized by high quality requirements.
Since, in extreme cases, human life can be at risk using medical technology products, there are several regulations (e.g. MPG, FDA) that must be observed when developing medical devices. For this reason, M.TEC has developed a process for medical technology products within the framework of its own quality management.
Design engineering of medical technology products
In accordance with FDA requirements, the process comprises the two milestones Design Input and Design Output, which frame the central phases of product development. In addition to these two inevitable FDA-compliant milestones, the M.TEC MEDICAL process includes further milestones, which each form the completion of the project phases. This guarantees a planned and structured project flow and the conscious transition between the individual phases in the development process.
Sample devices in the medical technology products
- Respiratory equipment
- Analysis devices (for multivariate evaluations of blood, urine and other body fluids; for professional use in medical practices etc.)
- Defibrillators
- Monitors for OP use
- Infusors
- Perfusion pumps