Your trusted partner for medical device quality and regulatory compliance

Transform your compliance journey with solutions that combine clarity and precision. Elevate your product, your process, and your peace of mind.

12+

Years of Experience

End-to-end Regulatory Support

Assured Compliance

Purpose-driven Approach

Our Story

Vidha QRA Solutions is a specialized consultancy providing end-to-end Quality Management System (QMS) and Regulatory Affairs support for the medical device industry. We bring clarity, structure, and trust to your certification and audit journey — whether in India or for international markets. With deep domain expertise and a passion for regulatory excellence, we guide you through national as well as global requirements with structured, process-driven methodologies.

“Vidha,” derived from Sanskrit for “process,” reflects our commitment to systematic, lifecycle-based support—from design and documentation through audits and post-market surveillance. We believe that strong systems are the backbone of safe and effective healthcare innovations.

VIDHA QRA Solutions has been founded with a clear purpose — to simplify the regulatory journey for medical device innovators and manufacturers.

Our Mission

To simplify compliance and accelerate market access for medical device manufacturers by delivering expert guidance across Indian and global regulatory requirements. We empower our clients with practical, process-driven solutions that ensure quality, safety, and audit readiness at every stage of the product lifecycle.

Our Vision

To be a catalyst for quality, safety, and innovation in the medical device industry by enabling manufacturers to confidently navigate Indian and international regulatory pathways and bring safe, compliant medical technologies to patients everywhere.

Driven by Purpose, Guided by Values

Integrity

We maintain the highest ethical standards in all our regulatory and quality practices.

Precision

Every detail matters in regulatory compliance. We deliver accurate, thorough documentation

Collaboration

We work closely with our clients, fostering partnerships built on trust and mutual success.

We continuously update our knowledge to stay ahead of evolving regulatory landscapes

Life-long Learning

Our Workflow

1

Understand Your Product & Goals

Map the Regulatory Pathway

Support You Beyond Approval

Execute with Precision

Communicate Transparently

Maintain Ethics & Confidentiality

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3
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5
4

Why Choose VIDHA?

Expertise You Can Trust

Hands-on experience, backed by a strong understanding of global and Indian regulatory frameworks.

Personalized Solutions

We tailor every document, process, and support plan to your specific device class, regulatory pathway, and business goals.

Reliable & Confidential Support

We prioritize confidentiality, integrity, and compliance — ensuring your data and submissions are handled with care and professionalism.

Our services are focused, efficient, and aligned with your timelines and budgets.

Timely & Cost-Effective Delivery

Partner with us for Regulatory and QMS support

Helping you build a stronger, compliant, and more efficient medical device company

Compliance

Certification

Confidence

What you will get?