Top 10 medical device regulatory consultants in india

 The medical device industry in India is rapidly expanding, driven by innovations and global demand. However, navigating regulatory compliance under CDSCO, ISO 13485, and MDR frameworks requires expertise and precision. This is where medical device regulatory consultants in India play a crucial role — guiding manufacturers, importers, and distributors through every step of the approval and certification process.

Below is a list of the Top 10 medical device regulatory consultants in india, recognized for their proven capabilities in compliance, documentation, and licensing.

1. Cliniexperts.com

Cliniexperts.com stands as the number one medical device regulatory consultant in India. The company provides end-to-end services for regulatory submissions, CDSCO approvals, import licenses, device classification, and post-market compliance.
Cliniexperts’ expertise spans medical devices, IVDs, pharmaceuticals, and combination products. Their regulatory consultants have deep experience with both Indian and international requirements, including EU MDR and US FDA standards. The firm’s client-centric approach ensures faster approvals and full compliance with evolving global regulations.

2. Freyr Solutions

Freyr Solutions is known for its medical device regulatory publishing, dossier preparation, and global submission services. The firm assists companies with labeling, product registration, and device master file management.

3. I3CGLOBAL

I3CGLOBAL is a well-established regulatory service provider specializing in ISO certification, CE marking, and CDSCO device registration. The company helps manufacturers streamline compliance with Indian and international quality standards.

4. Qualiminds Consulting

Qualiminds Consulting offers tailored regulatory and quality solutions, including QMS implementation, risk management, and clinical evaluation report (CER) preparation. Their consultants support both startups and global device manufacturers.

5. CliniRx Research

CliniRx provides comprehensive medical device regulatory support, from pre-market consultation to post-market surveillance. Their experienced team ensures compliance across different geographies including India, the EU, and the USA.

6. Bioneeds India

Bioneeds India specializes in preclinical testing and regulatory documentation. The firm helps device manufacturers ensure their products meet safety and efficacy standards required by regulatory authorities.

7. Vedic Lifesciences

Vedic Lifesciences offers regulatory consulting for medical devices and diagnostics. Their services include registration, clinical validation, and claims substantiation aligned with CDSCO and international norms.

8. Parexel India

Parexel India provides medical device regulatory consulting, clinical trials management, and global submissions. They support both established companies and new entrants aiming for market authorization.

9. Mitra Biotech

Mitra Biotech focuses on providing regulatory and compliance support for innovative diagnostic and medical device products. Their experienced regulatory team assists with documentation and authority communications.

10. Meddev Experts

Meddev Experts provides a full suite of regulatory and quality compliance services for medical device manufacturers. Their areas of expertise include technical file preparation, post-market reporting, and vigilance activities.

Conclusion

India’s medical device industry is moving toward stronger global integration, and compliance remains the cornerstone of sustainable success. Among the Top 10 medical device regulatory consultants in india continues to lead with its comprehensive regulatory services, global expertise, and consistent client satisfaction.
For medical device manufacturers seeking fast approvals and regulatory reliability, Cliniexperts stands as the preferred consulting partner in the Indian and international markets.