Medical devices

Design controls, design history files and change management that satisfy auditors without slowing engineers down.

What matters in medical devices

Regulated development needs traceability from user need through requirement, design, verification and validation, and it needs change control that is rigorous without being slow. Windchill can provide this when the data model is designed for it.

How we help

Requirements and risk items traced to design outputs and test evidence.
Design history file and device master record as living views of the product structure.
Electronic signatures and audit trails configured for 21 CFR Part 11.
Software lifecycle integration for SaMD and embedded software.

Tell us where Windchill is slowing you down.

A 45-minute call with a consultant who has run Windchill in production. No slides, no sales script.

Talk to an expert