About Us

easyQ Solutions is a regulatory technology company specializing in cloud-native electronic Quality Management System (eQMS) tailored for the Medical Device industry. In addition to our advanced software solutions, we provide comprehensive regulatory services for US FDA, EU MDR/IVDR, CDSCO, and other global regulatory bodies.

Our goal is to transform outdated, manual, and siloed quality processes with a smart, cohesive platform that accelerates time-to-market, increases operational effectiveness, and promotes regulatory compliance.

ISO 13485:2016

Quality Management Systems for Medical Devices

21 CFR Part 820

FDA Quality System Regulation (QSR)

21 CFR Part 11

Compliance for electronic records and signatures

Our eQMS is designed for global, cross-functional teams, combines key QMS modules with audit- ready records, role-based access, and data encryption both in transit and at rest. All of this is inbuilt on a secure, scalable cloud infrastructure.

We are proud to offer India’s first Quality Management Software (eQMS) tailored for the unique needs of Medical Device companies completely compliant with global regulatory frameworks like:

US FDA

EU MDR

CDSCO (India)

Other global regional authorities

our mission

In the coming decade, our goal is to empower 10,000 medtech companies worldwide with innovative quality management solutions and expert regulatory support. This will ensure quicker market access, lower compliance risks, and a steadfast commitment to global safety standards

our vision

Our Vision is to become the premier global facilitator for medical technology companies, assisting them in introducing safe innovations to the market more swiftly by ensuring compliance with all international regulatory standards

Varun Trivedi Founder & CEO - easyQ Solutions

Why Us?

01

Team Expertise

100+ combined experience supporting global leaders and startups.

02

Global Regulatory Knowledge

Support for US FDA, EU MDR/IVDR, CDSCO and other global regulatory authorities

03

On-Time Project Delivery

Ensuring regulatory milestones are met without delays

04

Proven Track Record

Successful execution of 500+ complex projects.

05

Tailored Solutions

Customize solutions to meet specific client needs

06

Diverse Product Portfolio

Expertise in Ai Algorithms, Multi Parameter Monitoring Devices, Ophthalmic Devices, Digital Therapeutics, Patient Monitors, Wearable Devices, Blood Monitoring Systems, Digital Pathology, ECG etc.

Our Commitment

easyQ Solutions supports startups, SMEs, and large enterprises in navigating the complex regulatory compliance landscapes across the globe by offering both next-generation software and expert-led regulatory advice.

We are more than a software provider, we are your regulatory transformation partner, assisting you in bringing safer, compliant medical devices to market faster.

Meet the Minds Behind easyQ Solutions!

At the heart of easyQ Solutions is a dynamic team of experts with more than 100+ years of combined experience in Regulatory Affairs, QMS and Product Development specifically formed for the Medical Device sector.

Spread across pan India, our team have extensive experience and knowledge in navigating global regulatory frameworks defined by FDA, EU MDR, CDSCO and other global regulatory bodies.

In addition, our professionals are well versed in industry leading standards such as ISO 13485, ISO 14971, IEC 62304 and IEC 62366 ensuring your organization remains compliant at every stage of the product lifecycle.

easyQ Solutions team meeting in modern office
100+

Years of Experience

100+ Experience

Combined experience in Regulatory Affairs, QMS and Product Development

Global Expertise

Extensive knowledge in FDA, EU MDR/IVDR, CDSCO and other regulatory frameworks

Industry Standards

Well-versed in ISO 13485, ISO 14971, IEC 60601, IEC 62304 and IEC 62366

Full Partnership

We don't just guide - we partner to improve performance and functionality

Our Unique Approach

Each team member brings a unique perspective and skill set, enabling us to solve real-world challenges in Quality Management Systems (QMS) and regulatory compliance with precision and purpose.

Partnership Beyond Compliance

We don't just guide you through regulatory compliance, we partner with you to improve performance, increase functionality and proactively address any challenges that might have an impact on user satisfaction.

Whether you are launching a novel AI-based device or optimizing existing product, our team is here to help you succeed faster, smarter and with full confidence.