Who we serve / Equipment & precision
In regulated equipment, the procedure is part of the product.
What is happening
Feb 2, 2026
the FDA's Quality Management System Regulation took effect, aligning US device rules with ISO 13485.
US Food and Drug Administration7,300 vs 400
openings projected for biomedical equipment technicians over a decade, against about 400 new graduates a year.
Bureau of Labor Statistics figures, reported by DOTmed47%
of healthcare technology management professionals were over fifty in AAMI's 2021 survey.
AAMI, reported by DOTmed
Our view
For medical, laboratory and semiconductor equipment, a procedure is not a help file. It is a controlled document, and an auditor can ask for the version that was in force on any given day.
That makes change the expensive part. A design revision triggers a document revision, a review and a retraining, and the people who do that work are the same scarce engineers who should be designing the next product.
We think the way out is to derive the procedure from the design instead of writing it beside the design, so that the two cannot drift apart and a revision is a review rather than a rewrite.
Where Machinebase fits
- Assembly and service procedures drafted from the device's CAD.
- Each step shown on the exact model, down to the fastener.
- Procedures your own engineers review and edit before anyone follows them.