Questions people ask us
What IF MedTech does, in the words people use to ask: prototyping, design, manufacturing, CDSCO and global regulatory, and taking a device to market.
What does IF MedTech do?
IF MedTech is a medical device co-development company in Navi Mumbai, India, with a quality system certified to ISO 13485. It takes a device from a clinical need through design, verification, regulatory submission and manufacturing, and can co-invest in a product and help take it to market. It works through five services, Co-Innovate, Co-Design & Develop, Co-Manufacturing, Co-Commercialize and Co-Invest, with patents and IP running alongside.
Can IF MedTech build a prototype of my medical device?
Yes, through its Co-Innovate service: Idea validation, Proof of principle and Prototype / MVP. The prototype work covers a first working prototype, breadboard electronics and mock-up housings, and gives you something you can demonstrate to investors, boards or clinical partners.
Does IF MedTech design and develop medical devices?
Yes, through its Co-Design & Develop service, which takes a working idea to a medical-grade product and builds the design history file as the work goes. Nine disciplines work in one team under one ISO 13485 quality system: Industrial design, Mechanical engineering, Electronics, Embedded firmware & BLE, Mobile / web / cloud app, AI / ML, Verification & validation, India regulatory dossier and International regulatory.
Does IF MedTech manufacture medical devices?
Yes, through its Co-Manufacturing service: Design transfer, Pilot & small-batch, Larger-scale assembly, Sterile & assembly support and Post-market support. Volume assembly runs on its own audited lines in Navi Mumbai, with batch records, traceability, complaint handling and device history records from the first build.
Can IF MedTech help with CDSCO registration in India?
Yes. Its India regulatory dossier service prepares CDSCO submissions under the Medical Devices Rules, 2017, on the form that matches the device class (MD-3 for Classes A and B, MD-7 for Classes C and D, MD-12 for a test licence) and the pathway for software as a medical device. The dossier is assembled while the device is designed, so it is ready to submit at the end.
Can IF MedTech help with US FDA 510(k) or EU MDR CE marking?
Yes. It prepares EU MDR technical files and supports US FDA 510(k) preparation from the design file the device already has, and its global regulatory service covers US FDA 510(k), EU MDR CE marking, ASEAN, and Middle East and GCC pathways.
Can IF MedTech help take a medical device to market?
Yes, through its Co-Commercialize service: Global regulatory, Distribution partnerships, Marketing & sales enablement and Post-market intelligence. That means approval in the markets you are aiming at, distributor and country-partner setup, launch materials, and the field feedback that shapes the next version.
Does IF MedTech invest in medtech startups?
Yes, through its Co-Invest service, for founders who have the clinical insight but not the company around it. It can take equity, run the build, and either stay as the operating partner or hand the company over. The options are Seed funding, Business mentoring, Board / advisor placement, Build to Operate and Build to Transfer.
Is IF MedTech ISO 13485 certified?
Yes. Quality system certified to ISO 13485 by TÜV SÜD, valid from 2025 to 2028. The certificate and its scope statement are available on request. The certificate covers the quality system, not any one device: each device is still assessed against the standards that apply to it and its route to market.
What kinds of medical devices has IF MedTech worked on?
Devices in seven areas. In-Vitro Diagnostics: HbA1C analyser, micronutrient screening, haemoglobin quantifier, point-of-care biosensors. Surgical Instruments: Laparoscopic instruments, heart-valve templates, RF ablation electrodes, powered surgical handpieces. Hospital Equipment: Ventilators, oxygen concentrators, OT video recorders, Auto CPAP, organ transportation, blood warmers. Drug Delivery: Drug aerosolisers, nano drug delivery, dermal patches. Diagnostic Devices: Digital stethoscopes, diabetic foot screeners, glaucoma screeners, ECG patches, wearable multivital patches. Rehabilitation & Neonatal: Prosthetic legs, polio calipers, knee, hip and maxillofacial implants, phototherapy units, infant warmers. AI and SaMD: Dermatology screening platforms, tele-consultation platforms, image classification, clinical AI tools.
Who does IF MedTech work with?
Practising clinicians, startups, established manufacturers, foreign companies entering India, and research groups with IP. The site has a page for each: Clinician with an idea or a startup, Innovator-partnered startup, Established manufacturer, Foreign company or startup, Corporate spin-out and Research group with IP.
Where is IF MedTech, and how do I contact it?
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, Maharashtra 400709, India. Email management@ifmedtech.com or call +91 9970642575. The team is seventy-six people, forty-one of them engineers.
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