ISO 13485 certified quality system
CDSCO-licensed facility, Chennai
In-house SMT, assembly and test
Clinical studies across 14 Indian hospitals
What we do
Your path to market, built in house.
From first sketch to shipped units, under one quality system, one roof, one accountable team.
Medical device design and development
Concept through verified design, under design controls from the first requirement.
02New product introduction
Design transfer, pilot builds and process validation, finished when production is proven.
03Contract manufacturing
Units built, tested, released and supplied under our own quality system.
04Clinical research (CRO)
Study strategy, ethics approvals and evidence delivery across an Indian hospital network.
05Quality and regulatory affairs
Pathway, quality system and submission, set early and carried through.
Sectors we serve
The devices we build for.
Three categories, each with a different burden of proof.
Why RhythmRx
Why teams bring programmes to us.
01
One team across engineering, clinical and regulatory, not four vendors coordinating.
120 people across 12 disciplines, one accountable programme lead.
02
Manufacturing under our own quality system, not brokered out.
ISO 13485 scope covers design and manufacture, on our CDSCO-licensed Chennai site.
03
Clinical research delivered through an established Indian hospital network.
More than 2,500 patients enrolled to date.
Resources
Notes from the work.
Practical writing on device development, clinical evidence, manufacturing and regulatory strategy.
Viscosity is the design constraint nobody budgeted for
Divya Menon · 13 July 2026
Formulations above 200 mg/mL frequently exceed 20 cP, which quietly governs the entire injection device design space.
Read the articleDose is not what you set. It is what the tissue receives.
Vikram Sethi · 29 June 2026
Thirty watts for thirty seconds is not a dose. Delivering therapy through a variable, partially observable patient.
Read the articleSensitivity and specificity are not enough
Dr. Shalini Krishnamurthy · 15 June 2026
A test with 95% sensitivity and 95% specificity produces mostly false positives at 1% prevalence.
Read the articleNext step
Tell us where your device stands today.
The first conversation is short and specific. What you are building, what stage it is at, and what needs to happen next.