01Industrial Design
Form, ergonomics and user experience that make complex devices feel inevitable.
CONCEPTSIMPLIFYING INNOVATION — SINCE 2020
From first sketch to factory floor.
Unplex® is a full product-lifecycle consulting partner. We engineer the product, build the quality system that earns certification, and carry both through approval into manufacturing — for medical devices, defense and industrial automation.
01 — WHO WE ARE
Welcome to Unplex® — engineers, designers and regulatory specialists who take deep-technology products from first principle to production line. Your vision, our passion — one accountable partner.
02 — WHAT WE DO
Three ways in.
One partner throughout.
START HERE — MOST CLIENTS DO
Quality & Regulatory
Regulatory strategy and approvals for active medical devices and combination products — monitoring, diagnostics, SaMD and digital health. QARA built from systems engineering, ISO 13485:2016 at the backbone — US FDA, CDSCO, Health Canada and IMDRF-aligned markets. India to the world, the world to India.
Quality & Regulatory →Product Engineering
Multidisciplinary, cross-functional systems engineering — nine disciplines from systems definition to manufacturing support, built for mission-critical instrumentation.
Product Engineering →Digital Transformation
ISO 13485-ready Odoo ERP implementation, process automation and web development — operations as compliant as your product.
Digital Transformation →03 — PRODUCT ENGINEERING, END TO END
Nine disciplines.
One unbroken chain.
01 / 09
01
02System Design
Architecture across electronics, mechanics and software — decided before a single part is made.
ARCHITECTURE
03Hardware Design
Schematics, PCB layout, signal integrity and EMC-aware electronics engineering.
ELECTRONICS
04Mechanical Design
Precision CAD, DFM, tolerance analysis, enclosures and mechanisms built to be built.
MECHANICS
05Software
Embedded firmware to cloud — developed with IEC 62304 discipline from day one.
FIRMWARE / CLOUD
06Sourcing
Vetted supply chains across India and North America that keep your BOM honest.
SUPPLY CHAIN
07Prototyping & DFM
Looks-like, works-like builds that surface risk early — and often.
VALIDATION
08Compliance
ISO 13485, IEC 62304 and FDA pathways — engineered in, never bolted on.
REGULATORY
09Pilot Production
From validated design to first articles and scale-ready manufacturing.
MANUFACTURING04 — INDUSTRIES WE SERVE
Built for industries
where failure isn't an option.
Medical Devices & Life Sciences
Class-conscious development under ISO 13485 and FDA frameworks — from wellness wearables to clinical instruments and IVD.
Defense
Rugged, secure, mission-ready systems engineered to perform in the field, not just the lab.
Industrial Automation
Sensing, control and robotics that keep production lines moving — designed for uptime.
05 — HOW WE WORK
Six values. Zero shortcuts.
V/01
Empathy
We design for the people who will hold, wear and depend on the product.
V/02
Trust
Relationships built on integrity, confidentiality and respect — IP stays yours.
V/03
Excellence
We hold ourselves to higher standards than the standard requires.
V/04
Creativity
Diverse ideas, first-principles thinking and the courage to simplify.
V/05
Grit
Hard problems are why we exist. We stay until they're solved.
V/06
Long-Term Thinking
Sustainable engineering decisions that still look right a decade later.
06 — THREE TIME ZONES, ONE TEAM
Always on, somewhere.
07 — THE LIBRARY
Answers before the call.
Free tools, interactive blueprints and AI assistants built from the questions our clients ask most — plus Academy, our learning path for startup founders and fresh graduates.
07 LIVE
Browse the full library →
Tools
Device classification, CDSCO fees & timelines, FMEA and design-transfer templates.
03 MAPSBlueprints
Interactive roadmaps for ISO 13485, IEC 62304 and FDA low-risk wellness.
COPILOTSAI Assistants
Regulatory, SaMD and clinical-evaluation copilots for medtech teams.
NEW — 5 LESSONSAcademy
The deep-tech product lifecycle, taught for founders and fresh graduates.
08 — QUESTIONS, ANSWERED
Asked before anyone signs.
What makes Unplex® different from other design houses?+
One owner of the whole lifecycle — design, engineering, compliance and production held together by a single systems-engineering thread, whether disciplines sit with us, with you or with partners. No accountability gaps, no surprises at the regulatory finish line.
How do you protect our intellectual property?+
Every engagement starts under NDA. Your IP remains yours — designs, source files and documentation are delivered in full, and our internal access controls keep projects compartmentalized.
How long does it take to go from idea to product?+
It depends on class and complexity, but our agile cadence delivers a works-like prototype in months, not years — with compliance documentation building in parallel, not after.
Can you take over a project that's already in progress?+
Yes. We regularly inherit stalled designs, audit them against the target standard, and re-plan the shortest defensible path to production.
HAVE A PRODUCT IN MIND?
Let's talk.
Book a 15-min intro call→
info@unplex.tech