A medical breakthrough is only the beginning.
A promising medical technology begins with possibility. Bringing it into the real world takes more. It takes credible evidence, clinical confidence, regulatory clarity and manufacturing that holds up at volume.
RhythmRx connects these disciplines so that the decisions made in week one still hold at submission and at scale.
The five services
Five disciplines, one continuous programme.
Concept through verified design, under design controls from the first requirement. Electronics, firmware, mechanical, software and human factors run as one team rather than as handoffs between specialists.
- Product definition, user needs and requirements
- Electronics, firmware, mechanical and regulated software
- Verification, validation and design history documentation
The project that turns a validated design into something that can be built repeatably. Design transfer, design for manufacturing, pilot builds and process validation, finished when production is proven.
- Design transfer and manufacturing documentation
- Pilot builds, jigs, fixtures and first-article inspection
- Process validation and production readiness
Ongoing production under our own quality system. Electronics manufacturing, device assembly, functional test, quality release and supply, batch after batch, with unit-level traceability.
- SMT, assembly, functional test and calibration
- Batch records, QC release and change control
- Supplier qualification and continuity planning
Study strategy, ethics approvals, site execution and evidence delivery, run across an established hospital network in India and built around how the device is actually used.
- Protocol development and Ethics Committee approvals
- Clinical validation and performance evaluation
- Monitoring, data management and biostatistics
Regulatory strategy set early and carried through the programme, so the technical file is assembled from work that was already being done rather than reconstructed at the end.
- Regulatory strategy and pathway definition
- Quality management systems and design controls
- Submissions and post-market compliance
Sectors we serve
Built for the devices we know best.
Three device categories where our engineering, clinical and regulatory experience compounds.
Diagnostic devices
Devices that have to produce the same answer in a ward, a clinic and a patient’s home.
Diagnostic devicesTherapeutic devices
Active devices that deliver therapy, where the margin for failure is narrower and the evidence bar is higher.
Therapeutic devicesDrug delivery
Delivery devices and combination products, engineered for dose accuracy and real-world use.
Drug deliveryOne connected programme
Because no part of the device journey stands alone.
Clinical research shapes evidence. Evidence strengthens the submission. The submission depends on documentation built during development. Manufacturing has to reproduce exactly what was validated. At RhythmRx these are not separate checkpoints handed between vendors. They are one connected programme, so a decision made today strengthens every milestone that follows.
Next step
Have a programme to discuss?
Tell us what you are building and what stage it is at. The first conversation is short and specific.