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You have a validated design. You need it built, and built in a way that holds up when a notified body or auditor looks at how it was made. That means knowing where every part came from, who assembled it, what was tested, and what changed between builds. A standard contract manufacturer doesn’t think this way. They fill orders. They don’t track component substitutions against your design specification or flag when a supplier change could affect your regulatory file.
At MDS+, medical device manufacturing runs under ISO 13485 quality controls because that is the only way a medical device build is actually repeatable and defensible. Your PCBA, mechanical assembly, supplier qualification, incoming inspection, functional testing, and build records are managed as one connected process. Whether you need 50 units for a clinical trial or 2,000 for an early commercial launch, the build is controlled, documented, and ready for your next regulatory step.
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Parts, assembly, testing, and build records managed under ISO 13485 quality controls from the first unit to the last.
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PCBA, housing, cables, sensors, and packaging brought into one clean, traceable assembly process.
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Supplier selections, incoming inspections, and any part changes tracked, documented and approved before they affect your build or your file.
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From working units to controlled pilot runs to serial production, with clear build notes, cost checks, and risk flags at every stage.
PCBA, mechanical assembly, supplier control, incoming inspection, functional testing, build records, quality assurance and production support under ISO 13485.
Yes. We manufacture medical devices in Singapore under ISO 13485 with supplier oversight, quality controls, and full build documentation.
It depends on the device complexity, but typically we support 50-unit clinical trial builds through to 5,000-unit early commercial runs. Too small for large CMOs, right for MDS+.
Risk assessment and mitigation planning, supplier qualifications, incoming quality controls, assembly quality controls, functional testing before delivery, full traceability records, change management controls and approval flows. A high awareness that problems found early cost less.
Yes. Each build cycle produces supplier feedback, quality notes, and test results that feed directly into your production plan for the next batch.
