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Idea to impact
Medical-grade product development end to end, from a clinical need to a device on sale.
Medical device co-development · Navi Mumbai, India
We design, build and manufacture medical devices
From a clinical idea to a licensed product: design, prototyping, regulatory approval and manufacturing, by one team under one ISO 13485 quality system.
Who we are
IF MedTech designs, develops and manufactures medical devices for clinicians, startups and manufacturers, under one ISO 13485 quality system in Navi Mumbai.
- 76People on the team
- 41Engineers across nine disciplines
- 40+Devices designed and developed
- 100+Clinician partners
- 2ISO 13485 certified sites
What we do
Every stage of a device, with one partner
Start at the stage you are at. Each service can stand alone, and each one hands the next a complete record.
Co-Innovate
Turn a clinical need into a proven principle and a first working prototype.
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Co-Design & Develop
Take a working idea to a medical-grade product, with the design history file built as we go.
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Co-Manufacturing
Move a validated design into pilot batches and volume assembly at our audited site.
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Co-Commercialize
Approval, distributors and launch in the markets you are targeting.
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Co-Invest
Capital and an operating partner for founders with the clinical insight.
ExploreWho are you?
Start from where you are
Pick the one that sounds like you. Each page answers the first question that kind of buyer asks.
Clinician with an idea or a startup
You see the problem in clinic, and have an idea or a company formed around it.
Your first question
“Who owns the idea, and will it work as a device?”
You bring
The clinical problem, and your sketches, notes or prototype.
You leave with
A verified device, patent filings where they hold, and a route to patients.
You start with
Co-Innovate
See your full path
Innovator-partnered startup
You have a working prototype and the test results so far.
Your first question
“What does my prototype need to become an approved device?”
You bring
Your prototype, the test results so far, and the intended use.
You leave with
A verified device, patent filings, and units made under licence.
You start with
Co-Design & Develop
See your full path
Established manufacturer
You are adding a device to your range, or moving one into Indian production.
Your first question
“Can you work to my procedures, and fit my design history file?”
You bring
Your requirements or released design file, and your quality procedures.
You leave with
Records that fit your design history file, and batches made to them.
You start with
Co-Design & Develop or Co-Manufacturing
See your full path
Foreign company or startup
Your device sells elsewhere or is still in development, and you want it made and sold in India.
Your first question
“Do my approvals count in India, and who makes and sells the device here?”
You bring
Your approvals or target markets, and the design and technical file.
You leave with
An Indian dossier, India-made batches and distribution partners.
You start with
Co-Manufacturing
See your full path
Research group with IP
You have a lab result, its data and your filings, and want a device patients use.
Your first question
“Can my result become a product, and how do I protect it?”
You bring
The result and its data, your filings and papers, and your institution's policy.
You leave with
Patents shaped around a product, a prototype, and an asset to license.
You start with
Co-Innovate
See your full path
Corporate spin-out
You are building a new company and its device out of a larger one.
Your first question
“Who builds the team, funds it, and holds the licences?”
You bring
The agreement with the parent on IP and records, and the design file.
You leave with
A funded company with its own device, dossier and production.
You start with
Co-Invest
See your full path
Why choose us
Most programmes stall between a prototype and a product. We are set up so they do not: one team of nine disciplines, one quality system, and our own design office, labs and assembly lines.
Built to take a device all the way
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Integrated facilities
Design office, labs and audited assembly lines in Navi Mumbai, so an idea becomes a device quickly.
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Built for compliance
Every programme runs on an ISO 13485 quality system, with the design history file built as the work goes.
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Clinician partnerships
More than a hundred clinicians work with us on real clinical needs.
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One team, nine disciplines
Industrial design, mechanical, electronics, embedded, software, AI, verification and regulatory work in one team.
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Cross-border work
Support for companies entering India and for Indian devices going abroad.
End to end
Medical-grade product development end to end, from a clinical need to a device on sale.
Design, build and test under one roof. Our design office, labs and assembly lines in Navi Mumbai, compliant with ISO 13485 and the Medical Devices Rules, 2017.
Design, build and test under one roof
Our design office, labs and assembly lines in Navi Mumbai, compliant with ISO 13485 and the Medical Devices Rules, 2017.
Not sure where to start?
Answer a few questions first
The tools run in your browser. Nothing is sent to us.
Readiness checkEight questions on the need, the build and the market, and a plain verdict.
Intended useWrite the one paragraph the class, the tests and every claim follow from.
Class and routeGet the likely risk class under the Medical Devices Rules, 2017, and the licence it brings.Insights
Practical notes for device teams
Classification, standards and design records, explained with diagrams.
Regulatory
All insights How a medical device is classified in India
The Medical Devices Rules, 2017 put every device in one of four risk classes. The class decides who grants the licence and how much evidence you need, so settle it early.
RegulatoryIndia, the US and the EU: three routes to market, side by side
Each market has its own classes, its own regulator and its own route. One design file can serve all three, if it is planned for them from the start.
DesignSix standards that shape a device before testing starts
Most standards are thought of as test standards. Six of them decide design choices long before a device reaches a lab.
Working on a device?
Tell us where you are. We reply with what the next stage needs.
Not sure what you need?
Ask the IF MedTech assistant. Tell it about your device or your idea, and it explains what we do and which part of our work fits. You can ask up to 10 questions a day.