Design & Development for medical devices

In medical technology, design and development are governed by rules other industries do not know. ISO 13485 requires a controlled development process in clause 7.3, covering planning, verification, validation and design transfer. ISO 14971 requires risks to be controlled and evidenced across the entire lifecycle. And IEC 62366-1 requires proof that a device can be operated correctly even under time pressure. Anyone who designs without documenting that chain delivers a drawing — not a development service.

For buyers, the first question is therefore not which CAD system someone uses, but where the design history file is created and who owns it. If it stays with the service provider, your approval depends on them; if it is handed over, it must be complete and traceable. The division of labour changes nothing about responsibility: under the MDR, the manufacturer is whoever places the device on the market, not whoever drew it.

The providers listed here cover different depths. Some take on the concept phase and hand over with the requirement specification, others accompany the project through to series production including tooling and initial sample inspection, and others specialise in single steps: simulation, miniaturisation, material selection for sterilisable components. Looking at manufacturability early saves change cycles — and in a regulated environment, every cycle brings documentation with it.