MEDICAL DEVICES
Documentation is part of the product
Medical device manufacturing carries a documentation burden unlike any other sector. Device history records, full material traceability, controlled processes and validated changes are not administrative overhead — they are conditions of being allowed to sell. The practical problem is that maintaining them manually is slow, error-prone and expensive, and the records are often assembled after production rather than captured during it.
What these plants are up against
Device history, captured not compiled
The production record should be a by-product of manufacturing, written as it happens, rather than a document assembled afterwards from several sources.
Complete material traceability
Component and material genealogy through every stage, with the process conditions each unit experienced attached to it.
Controlled, evidenced processes
Parameters held within validated ranges, with deviations detected and recorded automatically rather than depending on someone noticing.
Change control and system validation
The systems holding these records are themselves subject to validation — which shapes how software is deployed, updated and documented.
A note on validated environments
Medical device manufacturing operates under regulatory frameworks that place specific requirements on computerised systems, including validation and change control. These requirements vary by market and device class. We would want to understand your regulatory position and your quality system's expectations early in any discussion, and we will be straightforward about what that means for how a system is built, deployed and maintained.
How we help
MES for Manufacturing
Live production tracking, OEE, downtime, quality and traceability - read directly from your machines.
LEARN MORETraceability & Genealogy
Every unit tracked with its parameters and history, so an audit is answered from the system in seconds.
LEARN MOREIndustrial AI
Predictive maintenance, visual inspection and process optimisation, grounded in the physics of the process.
LEARN MOREDISCUSS YOUR REGULATORY POSITION
Tell us about your process and your systems. We will tell you how we would approach it.