A design is only as good as the units that leave the line.
Manufacturing a medical device is not assembly. It is a controlled process producing identical, traceable, released units under a quality system that will be audited. Yield, supplier continuity, test coverage, batch records and change control decide whether a product survives its first year in the market.
RhythmRx manufactures medical devices in India under an ISO 13485, ISO 9001 and ISO 27001 certified quality system, in a CDSCO approved manufacturing facility. We build our own products on the same lines we build our clients’ products on.
Capabilities
What we manufacture, and how.
01
Electronics manufacturing
SMT assembly, through-hole, conformal coating and automated inspection for medical-grade PCBAs, built on our own lines.
02
Device assembly and integration
Enclosure assembly, wearable build, cable and sensor integration, and final device build under controlled work instructions.
03
Functional test and calibration
Fixture-based functional test, calibration against reference standards, and unit-level test records retained for traceability.
04
Quality control and release
Incoming inspection, in-process checks, final QC, batch record review and documented release. Non-conformance and CAPA handled inside the quality system.
05
Supply chain and sourcing
Supplier qualification, component sourcing, obsolescence monitoring and continuity planning for long-lifecycle medical products.
06
Labelling, packaging and traceability
Device labelling, UDI, serialisation, packaging and full unit-level traceability from component lot to shipped device.
What you get
What you get with every batch.
Full unit-level traceability.
Retained test records.
Reviewed and signed batch records.
Documented change control.
Next step
Need a manufacturing partner?
Send us the design package and the volumes you are planning for. We will tell you what onboarding looks like.