IF MedTechBuild with us

About

Our mission is to build need-based, user-centric medical devices of high quality, through interdisciplinary expertise, AI-driven systems, optimised processes and translational research. Four things decide what we take on: innovation, quality, the patient, and the burden carried by the people who deliver care.

What we do
Project planning, regulatory and compliance, industrial design, mechanical design, electronics design, and assembly and testing, under a quality system certified to ISO 13485.
Who we work with
Practising clinicians with an idea, founders building a first device, research groups holding intellectual property, and established manufacturers bringing a product into India or taking one out of it.
How we work
Co-development rather than a brief and a specification. We take the design decisions with you and carry them through to a device that can be manufactured and submitted, and where it fits we invest in the product alongside you.

In numbers

  • 76people
  • 41engineers
  • 40+devices designed and developed
  • 100+clinician partners
  • 2certified sites

What we do

Where we work

Design, development and manufacturing

Office No: 1101/02/03/04, 11th Floor, KAMDHENU 23 WEST, Plot No. A-10/2 & A-11, Thane-Belapur Road, Kopar Khairane, Navi Mumbai 400709

Certificate 99 400 00046/01 · Map

Manufacturing

3rd Floor, Plot A-22, TTC Industrial Area, Khairane, Navi Mumbai 400705

Certificate 99 400 00046/02 · Map

How we are certified

TÜV SÜD certification markISO 13485:2016Medical devices quality management systemCertified

The quality system covers design, development and manufacturing at both sites. The certificate and its scope statement are available on request.

Device areas

Co-development, not a brief handed over

A design firmDesigns to your briefHands over the filesYou find a makerIF MedTechDesigns with youBuilds the design fileMakes and submitsA contract makerBuilds your designNeeds a fixed designStarts at productionHow we work

We take the design decisions with you and carry them through to a device that can be manufactured and submitted. The design history file is built as the work goes, so the same team that designs the device can transfer it to production and support the dossier. Where it fits, we invest in the product alongside you.

How an engagement starts

  1. Step 1

    You write to us

    Tell us what you need through the enquiry form. A person on the team reads it.

    Contact us
  2. Step 2

    A first conversation

    We reply with questions, or with the people who should talk to you.

  3. Step 3

    Confidentiality first

    If there is a fit, we agree a confidentiality agreement before any detail changes hands.

  4. Step 4

    Scope in writing

    We agree the stages, the deliverables and the terms in a statement of work.

  5. Step 5

    The programme starts

    A project manager and the discipline leads your device needs take it on.

Questions clients ask

Do you work with companies outside India?

Yes. We work with established manufacturers bringing a product into India or taking one out of it, and with foreign startups. See Foreign company or startup.

Can you take on one part of a device, such as the electronics?

Yes. Each discipline is offered as a service on its own, from mechanical engineering to verification and validation.

Who owns what we build together?

Ownership of the design and of any inventions is agreed in writing before the work starts, as part of the statement of work.

Where are you based?

In Navi Mumbai, at two sites certified to ISO 13485. See the sites and the certificate.

Inside our facilities

The open-plan design office
Design office
Two engineers reviewing a CAD model on a laptop
Mechanical design
An engineer soldering a circuit board under a magnifier
Electronics design
Designers sketching on a tablet in front of a board of notes
Industrial design
Two engineers reviewing documents on a monitor
Regulatory and compliance
An assembly bench with tools and parts trays
Assembly and testing

Devices we have worked on

We name the type of device, not the client. Client work stays confidential. See every device type.

Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.

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.

Or send an enquiry