Engineering for medical devices

In this directory, engineering covers the work between design and series production: process development, automation, special-purpose machinery, fixture and tooling design, production planning. It is the work that decides whether a design can be manufactured economically and reproducibly — and, in medical technology, whether the process can be validated.

That is precisely the difference from other industries. Wherever a manufacturing result cannot be fully verified — welding, bonding, sterilising, injection moulding — ISO 13485 requires process validation: installation qualification, operational qualification, performance qualification, plus ongoing monitoring of critical parameters. A line that runs is not thereby accepted; it is accepted once there is evidence that it delivers the same result within defined limits.

For buyers, then, it matters less which controller someone installs than how they document qualification and who carries responsibility for it. The providers listed here cover different stages — from a single fixture through linked assembly lines to accompanying entire relocations.