Diagnostic Consumables
Sample Tube Assemblies
Multi part sample tube assemblies combining a tube, an insert and a closure.
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Industry Article
What ISO 13485 Means For Your Molded Parts
A plain reading of what a molder's ISO 13485:2016 certificate does and does not promise about the parts in your carton.
It Is A Quality System Certificate
ISO 13485:2016 certifies the quality management system of the site, covering how work is controlled, recorded and corrected. It does not by itself certify any individual part, and no molder should present it as though it does.
What It Should Change In Practice
In a certified plant, traceability is not optional. Every lot should tie back to a tool and a machine, corrective actions should be recorded, and a change to a tool should leave evidence behind it. Our ERP system is where that lives.
What It Does Not Cover
It does not mean parts are sterile, it does not make the molder your registered manufacturer, and it does not remove your own validation obligations. We hold ISO 13485:2016 and ISO 9001:2015 and still ship non sterile parts for you to validate.
How To Use It In Supplier Selection
Treat the certificate as a precondition rather than a differentiator. Once two suppliers both hold it, the real comparison is whether the tool room, the clean room and the molding floor are on one site and whether sampling records exist cavity by cavity.
Questions Buyers Ask
Questions On This Topic
Which certifications do you hold?
ISO 9001:2015 and ISO 13485:2016, with EN ISO 13485:2016 also shown on our certificate records.
Does your certification make our device compliant?
No. It supports your supplier file. Device registration and release remain with your own registered manufacturer.
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Components Mentioned Here
Diagnostic Consumables
Reaction Cup
Molded reaction cups for automated analysers, where the optical path runs through the wall and a thickness variation reads as a result error.
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Syringe And Catheter Components
IV Catheter Components
Molded hubs, wings and housings for intravenous catheters, shown here coming off the production line.
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Related Pages
Case Study
Water Tightness Validation On A Container And Closure Pair
A container and a closure can each pass dimensional inspection and still leak together, because the seal is a property of the pair and not of either part alone.
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Industry
Medical Device OEM
Single use delivery and access devices where the tool, not the moulding machine, decides whether the device works.
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Industry
IVD And Diagnostics
Analyser consumables and sample handling parts where a moulding variation becomes a result variation.
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Solution
Clean Room Injection Molding
ISO 8 clean room molding and packing for parts that touch a sample, a drug or a patient.
See The Stages →Put This Into Practice On Your Own Part
Send the drawing and we will apply exactly what this guide describes to your geometry, and tell you where it will not work.