Coherent Intelligent Systems, Expertly Crafted.

Your end-to-end engineering partner for mission-critical, regulated products. We build medical devices, Industrial IoT, and AI-enabled software — taking your ideas from concept and first prototype through full FDA and IEC certification.

Start a project → See our expertise

In-house products

QMS Studio

AI-centric compliance & document management for QARA teams.

OPD Queue Manager

Intelligent OPD queue & triage with automated risk scoring.

Cardiac Bioacoustics

Synchronized ECG, PCG & PPG diagnostic analytics platform.

Combined Experience

150+years

Domains

Medical

Industrial

Telematics/Datacom

Founded by engineers from

GE · Philips · HP · Wipro · Tektronix

Standards we engineer

IEC 60601 IEC 62304 ISO 13485 ISO 14971 ISO 27001 ISO 26262 IEC 61508 US FDA 510(k) CDSCO

About Coherentix

Engineering depth, real-world delivery.

Founded by a collective of seasoned engineers, we operate at the intersection of embedded systems, cloud, data, and AI — building products that have to work in the real world, not just the demo.

Who we are

Coherentix Labs is a global technology company founded by a collective of seasoned engineers and consultants with over 150 years of combined experience. Our roots lie in deep product engineering expertise across embedded systems, software platforms, and hardware.

We bring together hardware and software proficiency in one team, and have delivered products across medical devices, industrial automation, networking infrastructure, and healthcare platforms.

At our core, we're engineers who understand not just technology, but the discipline of building reliable, scalable, and intelligent systems.

What we do

We help clients turn ideas into intelligent, compliant, market-ready products — for startups and enterprises alike — through engineering precision and deep domain understanding.

Our services span the full lifecycle, from concept and prototyping to regulatory-compliant deployment, particularly in medical and healthcare, where we navigate US FDA 510(k), IEC 60601, IEC 62304, and ISO 14971.

Beyond healthcare, we design connected solutions for industrial automation, automotive systems, and consumer electronics.

Why Coherentix

Why teams choose Coherentix.

Senior engineering depth across hardware, software, AI, and regulated product delivery.

Full-stack product engineering

Hardware, firmware, cloud, apps, data, and AI delivered by one integrated technical team.

Regulated-domain discipline

IEC, ISO, FDA, CDSCO, and QMS-aware engineering from early architecture through validation.

Prototype to market

From PoC and board bring-up to cloud deployment, compliance testing, and release support.

Medical + industrial depth

Experience across patient monitoring, surgical devices, industrial IoT, and clean-tech systems.

AI with product context

Diagnostic imaging, anomaly detection, compliance automation, and RAG/agentic workflows.

Confidential execution

NDA-ready engineering support for startups, enterprises, and strategic technology partners.

Engineering Capabilities

Where we go deep.

Production-grade engineering across regulated domains, complex hardware, and intelligent software.

Capability 01 / 04

Regulated Product Engineering

Full-lifecycle design and engineering built around strict compliance frameworks.

Medical & Healthcare: Patient monitors, wearables, infusion pumps, and implant monitors compliant with IEC 60601, IEC 62304, ISO 14971, and ISO 27001. Hands-on FDA 510(k) and CDSCO regulatory navigation.
IEC 60601 IEC 62304 ISO 14971 ISO 27001 FDA 510(k) CDSCO
Industrial Systems: Functional safety engineering for mission-critical industrial automation complying with IEC 61508.
IEC 61508
Automotive: Automotive-grade hardware and software compliant with ISO 26262 standards.
ISO 26262

Capability 02 / 04

Rapid Innovation & Consulting

Strategic technical execution tailored to early-stage startups and enterprise product teams.

Concept to PoC: Accelerated prototyping and proof-of-concept development to validate complex hardware and software architectures.
Technical Leadership & Advisory: Fractional CTO and engineering leadership, regulatory audit preparation for IEC 62304, FDA 510(k), and CDSCO, plus flexible IP ownership models.
IEC 62304 FDA 510(k) CDSCO

Capability 03 / 04

Applied AI & Data Intelligence

Next-generation AI integration for automated diagnostics and regulated operations.

Diagnostic & Sensing Platforms: Organ segmentation, computer-vision anomaly detection, and predictive event analysis.
Intelligent QMS & Compliance: AI-driven document management, artifact auditing, and automated compliance tracking.
GenAI Infrastructure: RAG-based domain knowledge systems, Agentic AI workflows, and LLM applications.

Capability 04 / 04

Core Engineering Stack

Deep technical execution across the entire software and hardware lifecycle.

Hardware & Industrial Design: From PCB layout to enclosure and low-volume production.
PCB / PCBA 3D Printing Enclosure Design Board Bring-Up DFM / DFA
Embedded Systems & Firmware: Low-level firmware and embedded platforms, from silicon to edge.
C / C++ RTOS Embedded Linux ARM MIPS Device Drivers Edge IoT
Software, Cloud & Test Engineering: Full-stack platforms, cloud infrastructure, and specialized test engineering.
Node.js Angular Java Microservices Docker Kubernetes Test & Measurement DAQ Signal Processing

Product and Design Success Stories

Featured Success Stories

Client engagements and in-house products we've delivered.

01 / 06

Enterprise Remote Patient Monitoring (RPM) Platform

Medical Devices & Digital Health

FDA 510(k) Cleared Multi-Site Deployment

Scope: Turnkey product engineering from initial concept through market launch and FDA clearance.
Engineering Highlights: Architected a wearable IoT medical device system connected to a data-intensive cloud platform. Designed a centralized command center supporting real-time event triaging, disposition, and diagnostic reporting across multi-site fixed and mobile environments.
Regulatory & Impact: Executed full-lifecycle engineering and standards compliance testing, securing successful 510(k) clearances across multiple portfolio products.

Ultrasound-Guided RF Ablation System

Client: Nesa Medtech · Surgical Devices

CDSCO Cleared

Scope: End-to-end engineering of a minimally invasive radiofrequency (RF) tissue ablation system.
Engineering Highlights: Integrated real-time ultrasound imaging to guide probe placement into target abnormal tissue, including uterine fibroids. Built a closed-loop protective feedback loop to precisely control thermal energy delivery and preserve surrounding tissue.
Regulatory & Impact: Achieved CDSCO clearance for clinical deployment.

EchoSense: AI Diagnostic Imaging Platform

Client: Nesa Medtech · AI & Diagnostic Software

In Active Development ICIICC 2026

Scope: Computer-vision software platform for automated organ segmentation and anomaly classification.
Current Capability: AI-driven detection and classification of uterine fibroids, in partnership with Nesa Medtech.
In Active Development: Automated diagnostic algorithms for expanded gynecological care, hepatic quantification, renal and urinary diagnostics, and gallbladder pathology.
Research: Presented paper at the International Conference on Innovations in Intelligent Computing and Communications (ICIICC 2026).

Multi-Tenant Centralized Smart RO Infrastructure

Client: DrinkPrime · Industrial IoT & CleanTech

Multi-Tenant IoT-Enabled

Scope: Architecture, system design, and rapid prototyping for a high-growth water-purification startup.
Engineering Highlights: Built an industrial-grade, centralized Reverse Osmosis (RO) platform equipped with IoT sensors to monitor, meter, and optimize water delivery across multi-tenant residential complexes.

Smart Kitchen IoT Appliance

Client: IoT Hardware Startup · Consumer Technology

Concept → PoC

Scope: Rapid concept-to-PoC product engineering for an early-stage consumer smart appliance.
Engineering Highlights: Developed the embedded system architecture, custom firmware, cloud IoT pipeline, and edge-intelligence protocols to turn a high-level concept into a functional, market-ready proof of concept.

In-House Products

AI, Clinical Workflow & Diagnostic Platforms

QMS Studio: AI-centric compliance and document management system for agile product and QARA teams, with automated requirement reviews, AI-assisted ISO 13485 auditing, compliance verification, and real-time gap analysis.
Outpatient Department Queue Manager System: Intelligent OPD queue and triage platform that captures patient history, vitals, symptoms, and diagnostic reports via voice and digital inputs, with risk scoring to escalate critical patients.
Multi-Modal Cardiac Bioacoustics Platform: Non-continuous diagnostic device integrating synchronized ECG, PCG, and PPG sensors to deliver synchronized cardiac performance analytics.

Customers

Trusted by Leaders & Innovators.

We partner with pioneering startups, global technology enterprises, and strategic engineering leaders to bring complex hardware, software, and AI solutions to market.

Featured Clients

Product teams and operators who rely on Coherentix for practical, cross-disciplinary engineering delivery.

Strategic Partnerships

Engineering Design Partner, supporting complex product and platform initiatives where execution quality matters.

Confidential Engagements

Trusted engineering partner to stealth startups and global enterprises under strict NDA agreements across medical, industrial, and IoT sectors.

How we engage

Design & Engineering Services.

From concept to commitment - A consistent six-stage delivery process, wrapped in the engagement model that fits your project.

Discovery

Understand the product, constraints, and regulatory path.

Design

Architecture, hardware/software split, and compliance strategy.

Build

Firmware, software, and hardware development in parallel.

Validate

Testing, V&V, and standards compliance verification.

Deploy

Manufacturing handoff, regulatory submission, and release.

Support

Ongoing maintenance, monitoring, and iteration.

Choose your engagement model

Flexible, cross-disciplinary design support tailored to your project scope, timeline and budget.

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Fixed-Price Turnkey Project

A fixed path, a fixed destination

Predictable budget, guaranteed results

Full end-to-end delivery of your product vision. We handle complete project execution — taking your concept from initial idea to proof of concept (PoC) or manufacturing-ready status, with total scope, compliance, and cost predictability.

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Monthly Dedicated Retainer

Same commitment, renews every month

Consistent hours, renewed monthly

A fixed allocation of senior consultant hours renewed monthly. Ideal for continuous, high-volume workloads that require dedicated, consistent expert focus.

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Floating Hours Retainer

One pool, used as you need it

Flexible hours, on-demand expertise

A flexible pool of senior credit hours valid over a set timeframe (typically 3 months, with extension options). Gives you on-demand access to specialized experts across multiple disciplines whenever project needs arise.

Coherent Intelligent Systems, Expertly Crafted.

Engineering depth, real-world delivery.

Who we are

What we do

Why teams choose Coherentix.

Full-stack product engineering

Regulated-domain discipline

Prototype to market

Medical + industrial depth

AI with product context

Confidential execution

Where we go deep.

Regulated Product Engineering

Rapid Innovation & Consulting

Applied AI & Data Intelligence

Core Engineering Stack

Featured Success Stories

Enterprise Remote Patient Monitoring (RPM) Platform

Ultrasound-Guided RF Ablation System

EchoSense: AI Diagnostic Imaging Platform

Multi-Tenant Centralized Smart RO Infrastructure

Smart Kitchen IoT Appliance

In-House Products

Trusted by Leaders & Innovators.

Design & Engineering Services.

Discovery

Design

Build

Validate

Deploy

Support

Fixed-Price Turnkey Project

Monthly Dedicated Retainer

Floating Hours Retainer

Tell us what you're building.

Address

Email us