Most medical device companies looking for an Indian design partner face the same problem. They find either a pure design company with no compliance capability, or a regulatory consultant with no engineering team. Neither gets the device to market.
At iMAC, we are an ISO 13485:2016 certified medical device design company based in Ahmedabad, India. We design the device and build the compliance documentation in parallel, so there is no gap between what gets engineered and what gets submitted to CDSCO, CE, or FDA.
TRUSTED BY LEADING BRANDS
Before reading further, confirm your device type is in our portfolio. iMAC has designed and delivered medical devices across these categories.
NOX Series: Artha, Urja, Advaita, and Digital Ananta. Nitrous oxide analgesia machines for dental and paediatric use. Class II. Metal enclosure. We took this product family from concept through product engineering to manufacturing.
Patient Warmer Igniva. Critical care equipment for ICU environments with a plastic ABS enclosure. We took this device from concept through testing and validation.
Biotech Footpadel. Eye surgery foot controller for ophthalmic surgeons. Class II. We took it from concept through validation.
GITA Mediquip Hospital Bed. We delivered full product engineering from concept through prototyping and validation.
Pill Cap. Connected medical device with embedded electronics. We took this project from concept through injection molding production.
Centrifuge Machine. We delivered this precision laboratory instrument from concept through prototype.
Medical Self Examine Kiosk. We designed this patient screening kiosk for clinical and public health settings.
Pure design companies stop at CAD. Pure regulatory consultants stop at documentation. iMAC covers the complete journey under one ISO 13485 certified roof.
For global companies in the USA, UK, Canada, Europe, and the Middle East, outsourcing medical device development to iMAC means working with an engineering team that operates under the same ISO 13485 quality management standard your regulatory submissions require, at a significantly lower cost than comparable Western firms.
We design form, ergonomics, and CMF specifically for clinical environments. Every concept is evaluated against the usability needs of the doctor, nurse, or patient who will use the device, with human factors documentation that supports IEC 62366 requirements.
We handle structural design, tolerance analysis, and enclosure engineering for medical-grade plastics and metal. IP ratings and sterilization compatibility are addressed at design stage, because enclosure decisions directly affect IEC 60601 safety and IP certification.
We design PCB layouts, medical-grade power management, wireless connectivity, and firmware for connected medical devices. Electrical safety is evaluated during schematic design so issues do not appear only during IEC 60601-1 and IEC 60601-1-2 testing.
We initiate the Design History File, produce DFMEA, build risk management documentation per ISO 14971, assess biocompatibility per ISO 10993, and prepare the essential principles checklist for CDSCO submission alongside engineering.
We build functional prototypes for pre-clinical evaluation and design validation. Alpha and beta models are developed to generate the verification and validation evidence required for ISO 13485 and CDSCO licensing.
We conduct DFM review for medical-grade plastics, sheet metal, and injection molding before any tooling commitment. Production documentation is prepared to support Device Master File requirements and a smoother manufacturing license path.
Medical Devices Rules 2017 for India. We map device classification, technical documentation, risk management, and biocompatibility requirements from the concept stage.
iMAC operates under an ISO 13485:2016 certified quality management system that is independently audited annually against the same standard your submission will reference.
Risk management documentation is produced as a mandatory deliverable at every development stage and built alongside engineering, never as an afterthought.
We evaluate patient-contacting materials against ISO 10993 requirements during design stage, before material choices and tooling are locked in.
We review PCB layout, enclosure design, and power supply decisions against IEC 60601 requirements before formal laboratory testing begins.
For clients targeting Europe, we prepare technical files aligned with MDR requirements while keeping engineering decisions consistent with the intended regulatory route.
For US-based clients, we align design documentation and quality system practices with FDA 21 CFR Part 820 expectations from the beginning of development.
NOX Artha, NOX Urja, NOX Advaita, NOX Digital Ananta. We took this from concept through product engineering to manufacturing under ISO 13485 aligned quality management. The NOX Series is now in active clinical use across India.
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ICU Equipment ICU medical equipment · ICU and medical staff · Plastic ABS enclosure We took this from concept through engineering, prototyping, testing, and validation. We evaluated IEC 60601 requirements throughout the engineering process.
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Precision eye surgery foot controller for ophthalmic surgeons. Class II. Plastic ABS enclosure. We addressed human factors from the first sketch and took it from concept to validation.
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Medical equipment for hospital staff and patients. We delivered full product engineering from concept through prototyping and validation, including structural analysis, ergonomic evaluation, and manufacturing documentation.
Read case studyThe biggest reason medical device submissions get rejected or delayed is documentation assembled after engineering was done instead of built alongside it. We build regulatory documentation as part of engineering, not after it.
We define the intended use, intended user, and intended environment. We map CDSCO device classification and identify the standards that apply across all target markets before detailed design begins.
Deliverables include the intended use statement, regulatory pathway document, risk management plan, and IP gap assessment.
We evaluate concept directions against device requirements, regulatory pathway, and manufacturing feasibility. IP protection is addressed before detailed engineering starts.
Deliverables include concept sketches, a feasibility report, preliminary DFMEA, and invention disclosure.
We develop industrial design, mechanical engineering, and electronics under ISO 13485 quality management. Every design decision is documented as it is made, not reconstructed later for submission.
Deliverables include CAD files, engineering drawings, DFMEA, DHF initiation, and design input and output documentation.
We build functional prototypes for design verification and validation. Pre-compliance IEC 60601 evaluation is completed before formal laboratory testing, and biocompatibility assessment is carried out for patient-contacting materials.
Deliverables include the functional prototype, verification and validation reports, pre-compliance evaluation, ISO 10993 material assessment, and usability study documentation.
We transfer the validated design to production with complete manufacturing documentation and DFM review before any tooling commitment. The production package is aligned with ISO 13485 and licensing requirements.
Deliverables include the DFM report, BOM, manufacturing drawings, quality plan, and Device Master File contribution.
Common questions from founders, OEMs, and international teams evaluating medical device development support in India.
It is the process of taking a device concept through industrial design, engineering, prototyping, regulatory documentation, and validation. Every design decision must be documented, every material evaluated for biocompatibility, and every design change assessed for risk so the final output supports a complete Design History File.
Indian medical device design companies like iMAC can offer ISO 13485 certified quality and alignment to CDSCO, CE MDR, and FDA expectations at a significantly lower cost than many Western firms. The goal is to reduce development cost without reducing engineering quality or regulatory credibility.
CDSCO is India's national regulatory authority for medical devices under the Medical Devices Rules 2017. If you manufacture, import, or sell a medical device in India, registration or licensing is mandatory, with Class A and B routed through State Licensing Authorities and Class C and D requiring central CDSCO approval.
Yes. We work with founders who have a device concept but no internal engineering team. We guide the project from the first sketch to a CDSCO-ready device, combining engineering and compliance support in one engagement.
ISO 13485:2016 is the quality management standard for medical device design and development. iMAC operates under this certified system for every project, which matters because many general product design firms claim medical experience without actually working inside a medical-device-specific quality framework.
A Class A or B device typically takes around 9 to 18 months to reach a submission-ready state, and CDSCO registration for Class A and B usually takes another 3 to 6 months after submission. Building documentation alongside engineering helps shorten avoidable delays.
A Design History File is the complete record of how a medical device was designed, including design inputs and outputs, review records, verification and validation evidence, and design transfer documentation. We initiate and maintain it from the engineering stage onward.
ISO 13485 governs how the design and development process is managed. IEC 60601 governs the safety requirements the device itself must meet. We address both, evaluating IEC 60601 implications during engineering before formal lab testing begins.
Tell us about your device concept, target users, intended market, and current development stage. We will outline the engineering path, documentation requirements, and likely compliance milestones before you commit.
We respond within 24 hours. NDA signed before anything is shared.
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