Co-Design & Develop

Take a working idea to a medical-grade product, with the design history file built as we go rather than reconstructed at the end. Nine technical disciplines under one roof and one ISO 13485 system.

Industrial design

How the device is held, read and operated, worked out with the people who will use it and tested against IEC 62366-1 rather than assumed.

Mechanical engineering

The physical device: the parts, how they fit and how they are made, with biocompatibility under ISO 10993 in view from the first material choice.

Electronics

Electronics designed to reduce the risk of failing safety and electromagnetic testing. Insulation, leakage and emissions are set against IEC 60601-1 at schematic stage, not after a failed test report.

Embedded firmware & BLE

The firmware inside the device, written under the IEC 62304 lifecycle. Battery life, wireless reliability and update security are design decisions, not later fixes.

Mobile / web / cloud app

The phone, browser and server software the device talks to, developed under IEC 62304 alongside the hardware so the two are verified together.

AI / ML

Models built on clinically labelled data, with the dataset, the training record and the performance evidence assembled the way a regulator will ask to see them.

Verification & validation

Proof that the device meets its requirements and works in real hands. Every protocol traces back to the risk file held under ISO 14971.

India regulatory dossier

The Indian submission assembled while the device is being designed, so the dossier is a collation at the end rather than a rewrite.

International regulatory

What the US and the EU ask for, prepared from the design file you already hold rather than rebuilt market by market.

01
Write the inputs
Needs turned into requirements that can be tested, each with a number.
02
Design in stages
Iterations with a design review at each stage, and the decisions recorded.
03
Verify
Each output tested against the requirement it answers.
04
Hand over
Design outputs released, with the design history file built as the work went.