The Unified Partner Behind
Smart Devices
NexorTest is the integrated regulatory, testing, manufacturing
and quality partner for software-based medical devices.
Mission & Vision
The principles that guide every project, design decision, and regulatory submission we deliver.
Our Vision
To be the unified partner layer for regulatory, testing, manufacturing, and quality enabling medtech companies to build and scale smart medical devices with confidence, speed, and compliance certainty.
Our Mission
Partner with small and medium sized medical device companies as their integrated backbone for regulatory strategy, quality systems, manufacturing coordination, and compliance testing eliminating vendor fragmentation and allowing founders and engineers to focus on innovation.
From Napkin Sketch To Global Commercial Launch
We partner with medical device companies with a particular expertise in software based medical devices (SaMD) and medical devices with embedded software to accelerate products from napkin sketch to global commercial launch. We handle:
Design & Engineering
Hardware, firmware, PCB, mechanical built with compliance in mind from day one
Manufacturing & Assembly
Prototype through production, maintaining regulatory rigor at every stage
Testing & Validation
EMC, cybersecurity, environmental, usability in ISO 17025 accredited lab
Global Regulatory
FDA, EU MDR, CDSCO, PMDA, NMPA, and 50+ additional regulatory pathways
One Unified Layer, Instead of Five Vendors.
Leadership Team
Rahul Kopparthi
Founder & CEO
Deep expertise in medical device regulatory strategy, software based medical devices, global market access, and product development across FDA, EU MDR, and emerging market pathways. Rahul saw firsthand how US and European medtech companies were losing months and millions trying to coordinate regulatory compliance, quality systems, manufacturing, and testing across fragmented vendors.
“Regulatory success starts with design and quality baked in from day one. The best companies don’t add compliance later they build it into their architecture, their code, their processes.”
Dr. Kumar Pabbisetty
Chief Compliance Officer
Dr. Kumar PBS Pabbisetty is a senior medical device regulatory and compliance professional with 21+ years of global experience across medical devices, diagnostics, digital health, and healthcare technologies. At NexorTest, he provides strategic regulatory leadership, helping organizations navigate complex global requirements and develop effective pathways for product approval, market access, and commercially aligned compliance.
The Core Team
Software Engineers
Validation expertise in firmware, embedded systems, and SaMD platforms.
Hardware Engineers
Analog, digital, RF, power electronics, and PCB design.
Regulatory & Quality Specialists
Have shepherded devices through FDA, EU MDR, and global pathways.
Manufacturing & Process Engineers
Scale products from prototype to commercial production.
We’re small enough to care deeply about each engagement, large enough to handle complex global launches and software heavy devices. Every person on our team is chosen for technical depth and collaborative mindset we’re partners with our clients, not vendors checking boxes.
A Gap That Was Crushing Medtech's Ability To Scale
In 2019, Rahul Kopparthi observed a critical gap in how US and European medtech companies approached global market entry regulatory and quality complexity was fragmenting their go to market strategy and crushing their ability to scale quickly.
The challenge wasn’t technical innovation US medtech teams were brilliant at design and engineering, especially in software. The bottleneck was fragmentation: FDA approval in the US, EU MDR compliance for European markets, CDSCO registration in India, PMDA in Japan, NMPA in China each market required a different approach, different documentation, often different vendors with no coordination.
Medical device companies faced a broken vendor model design firms who didn’t understand FDA requirements, regulatory consultants who couldn’t handle manufacturing, testing labs disconnected from certification expertise, quality teams operating independently, and authorized representatives scattered across regions. A device cleared for US FDA in 12 months could take another 18 months for EU + India entry. Teams hired 5-7 different vendors, spent 40-50% of their budget on overlapping and redundant work, and still faced surprise regulatory roadblocks in target markets.
NexorTest was founded to solve this. We built one integrated partner layer that owns design, manufacturing, testing, quality systems, and global certification so startups and mid market teams can scale from FDA to EU MDR to emerging markets on a unified timeline with coordinated strategy.
NexorTest Technologies offers end-to-end product development and testing services under one roof. Our services include product design and hardware development, EMC/EMI testing, environmental and reliability testing, safety testing, biocompatibility testing, software lifecycle and cybersecurity testing, and material testing.
We also provide global certification and regulatory compliance support such as CE, FCC, BIS, USFDA, EU MDR, EU IVDR, UKCA, and certifications for 50+ countries, helping products meet international standards efficiently.
Yes. NexorTest offers complete product design, engineering, and regulatory testing services under one roof.
Our team supports concept design, hardware development, prototype validation, compliance testing, and certification support, ensuring your product meets international standards and market requirements while reducing development time.
Absolutely. NexorTest assists with CE certification, FCC certification, BIS, CDSCO, EU MDR, USFDA, and global regulatory certifications, ensuring your product meets international compliance requirements.
NexorTest provides product testing and engineering services for multiple industries, including:
- Automotive and EV
- Aerospace and Defense
- Medical Devices and Healthcare
- IoT and Wireless Devices
- Telecom and Consumer Electronics
- Railway and Transportation
- Industrial Equipment and Manufacturing
Providing product design, product testing, engineering, and regulatory compliance services tailored to industry requirements.
Getting started is simple. You can contact us through the Contact Us page on our website or email us at market@nexortest.com. Our experts will review your product details and provide a customized design, testing, and certification plan tailored to your goals.
Yes. NexorTest provides integrated service packages covering design, testing, and certification, helping you save time and reduce costs.
Yes. NexorTest works with startups, SMEs, and established manufacturers, supporting projects from concept design and prototyping to testing, compliance, and certification. We help startups navigate regulatory requirements and product validation to accelerate market entry.
Yes. NexorTest supports clients worldwide, including companies targeting the United States, Europe, and other global markets. We help manufacturers meet international regulatory standards, EMC compliance requirements, and certification processes needed to launch products globally.
Ready to Take Your Product Global?
Tell us about your product, your target markets, and your timeline. We will build a tailored roadmap covering design, testing, and regulatory submissions all under one roof.