Where the chain
meets the patient.
Active medical devices and combination products — monitoring, diagnostics, SaMD and digital health. Unplex® designs, builds and approves them as one engagement: ISO 13485:2016 at the backbone, the patient at the end of the wire.
01 — WHAT WE BUILD
Active devices, from wearable to bench.
Patient Monitoring
Bedside and ambulatory monitors, vital-signs wearables — the body's signals, made trustworthy.
Diagnostics & POC IVD
Point-of-care in-vitro diagnostics built on optics and electromechanics.
Electrotherapy
Stimulation and therapy devices that act on the body — safely, by design.
SaMD
Software as a Medical Device, developed and documented under IEC 62304.
Digital Health
Companion apps and connected platforms that move regulated data safely.
Combination Products
Drug-device combinations at the device–pharma interface — both reviewers satisfied.
02 — THE STAKES
In medtech the chain ends at a person. Every link inherits the duty of care: the electrode must not harm, the algorithm must not mislead, the record must not be lost. We engineer with the patient at the end of the wire.
03 — HOW WE HELP
Three doors, all open.
Quality & Regulatory
Classification to approval — US FDA, CDSCO, Health Canada — on an ISO 13485:2016 backbone. India to the world, the world to India.
BUILDProduct Engineering
Device development under design controls and IEC 62304 discipline — from looks-like prototype to pilot production.
OPERATEDigital Transformation
ISO 13485-ready Odoo ERP for device manufacturers — traceability without the spreadsheet maze.
HAVE A DEVICE IN MIND?
Let's talk.BOOK 15 MINUTES — OR WRITE TO INFO@UNPLEX.TECH