Welcome to Vidha QRA Solutions

Your trusted partner in regulatory, quality, and compliance support for medical device manufacturers, ensuring adherence to both Indian and international standards with expertise and integrity.

"Vidha," derived from Sanskrit for "process," reflects our commitment to systematic, lifecycle-based support—from design and documentation through audits and post-market surveillance.

12+

Years of Experience

End-to-end Regulatory Support

Assured Compliance

Purpose-driven Approach

Regulatory Compliance Solutions

Expert consultancy for medical device manufacturers in regulatory, quality, and compliance support.

EU MDR Solutions

End-to-end support for CE marking under EU MDR— from classification and gap assessment to technical documentation and notified body engagement.

Quality Management Systems

Complete Quality Management System setup and implementation aligned with ISO 13485, ISO 9001, ICMED 13485, ICMED 9001, IMDR 5th Schedule

Complete regulatory support for CDSCO licensing under India’s Medical Device Rules, 2017 — from documentation to portal submissions and post-approval queries.

CDSCO/IMDR Compliance

India's first product-level certification - End-to-end support for MDR compliance - from classification and gap assessment to technical documentation and notified body engagement.

ICMED 13485 Plus Support

Clinical evaluation and Post Market Support

Comprehensive CER support — from planning and literature review to report writing, updates, and PMS documentation — aligned with regulatory requirements and your device lifecycle.

Risk Management Documentation

Comprehensive Risk analysis and risk management file preparation. ISO 14971-compliant strategies tailored to your medical device lifecycle.

Who We Help?

First-Time Applicants

Manufacturers Without In-House Regulatory Teams

Whether you're a Startup, SME, or an established manufacturer, we tailor our support to meet your specific product, process, and team needs.

Companies Transitioning from MDD to MDR

OEMs & Contract Manufacturers

Companies applying for government tenders or GEM portal listings

Startups & Innovation-Driven Enterprises

Established Manufacturers Seeking Market Expansion

Exporters & Importers Handling CDSCO or Foreign Market Approvals

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?