The medical cable assembly could not be validated without material declarations, and the original supplier could not provide them.
Specifying the medical cable assembly
The problem
A manufacturer of laboratory diagnostic equipment was close to design freeze on a new analyser, but validation could not be signed off because the cable assemblies in the design lacked material declarations. The original supplier had provided a general compliance statement but could not produce declarations for the specific part numbers, and could not commit to change notification.
What we found
The issue was one of provenance rather than specification. A supplier who assembles from bought-in cable stock cannot produce material declarations it has never received, and cannot notify a change it will not be told about.
What we supplied
Equivalent assemblies built to the same drawing, with material declarations based on our own incoming material control, documented change notification, and batch traceability so the validation records could be closed out. Electrical performance was verified against the original specification before shipment, so no re-testing of the device was required.
The outcome
Validation closed without a design change and without repeat testing. The supplier now appears on the manufacturer's approved vendor list with documented change control, which matters for a device with a long production life.
Products used in this project
Send us the application detail and we will confirm which of our connectors or cable assemblies suits the duty, or propose a custom construction. You can also review our quality control process and the documentation supplied with each order.
What this means for your project
For a device with a long production life, the ability to produce material declarations and to notify a change is worth more than a small unit-price advantage. It is the difference between a supplier you can validate and one you have to re-audit.
Reference material for the standards referenced above is published by ISO and the RoHS compliance guide. Where a project requires conformance to a particular standard, tell us at the enquiry stage and we will confirm what documentation we can supply.