Your Trusted Partner in
Regulatory Approvals Globally

At easyQ Solutions, we empower Medical Device companies to navigate complex global regulatory landscapes with ease. Whether it's FDA, EU MDR, CDSCO, and more other global regulatory authority, our in house expertise assures your innovation reach market faster and stays compliant

our clients

Trusted by Medtech Leaders Globally

Our Services Include

easyQ Solutions is a trusted regulatory partner for Medical Device manufacturers looking for smooth market entry across the U.S., India, Europe, and other global regions.

With deep expertise in FDA submissions, CDSCO registration, EU MDR IVDR compliance we help our clients avoid expensive delays and recalls ensuring full compliance across all device classes.

From strategy to submission, end-to-end support is provided by us, backed by years of experience and a strong success record, making us a dependable choice for regulatory consulting worldwide.

We support medical device manufacturers and companies with a comprehensive range of services including:

Proficiency in compiling complicated documents including:

510(k)
PMA
De Novo submissions
Technical Files
GSPRs
Plant Master Files
Device Master Files

Identification of relevant global cybersecurity standards for medical devices.
Detailed review and alignment of documentation with international guidance.
Ongoing support to keep up with evolving global cybersecurity expectations.

Development of human factor validation protocols.
Expert assistance in planning and conducting usability testing.
Support to ensure product design meets efficiency and user-safety standards.

Why easyQ Solutions as your Global Regulatory Partner?

Extensive Expertise in Global Regulations

Key regulatory frameworks, such as the US FDA, EU MDR/IVDR, UK MHRA, Health Canada, and CDSCO (India), guaranteeing seamless access to markets across the globe.

Comprehensive End-to-End Support

We provide complete regulatory support across the entire product lifecycle from initial strategy and classification to submission, approval, and post-market compliance.

Customized, Client-Focused Approach

We understand that every company and product is unique. Our solutions are customized to fit your unique objectives, schedule, and approach to the market.

Broad Product Experience

In-depth knowledge across a wide range of technologies including cardiac devices, point-of-care diagnostics, wearables, IVDs, AI/ML-based tools, and Software as a Medical Device (SaMD).

Solution-Oriented Team

We provide practical solutions in addition to consultation. Our result oriented approach ensures long- term compliance while speeding up approvals.

Our Expert Team

At easyQ Solutions, our team of regulatory specialists brings deep expertise in global compliance frameworks, including FDA (USA), CDSCO (India), EU MDR (Europe), and other international standards.Our mission is to simplify regulatory pathways while ensuring your submissions meet all applicable safety, performance, and documentation requirements—enabling you to confidently enter and succeed in global markets

Our goal is to make regulatory pathways more easier to manage while ensuring that your regulatory submissions completely comply with international safety standards, performance requirements, and documentation standards so that you can enter and succeed in global markets confidently.

50+

Combined Experience

Knowledge of Global Regulatory

Knowledge of different product

Proven Success

With a proven track record of supporting successful submissions from FDA 510(k) and PMA to CDSCO device registration and EU MDR Technical Files to other global submissions.

We have assisted startups to large enterprises in various regions to achieve regulatory success.