8C Healthcare

Regulatory Services in India

8C Healthcare offers comprehensive regulatory consulting services to global medical device manufacturers who intend to market their devices in India

SaMD QMS

8C Healthcare specializes in developing and establishing a Quality Management System (QMS) for enterprises around the globe that develop Software as a Medical Device (SaMD)

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Years Of Global Experience

Helping our clients to secure regulatory approvals and conduct clinical studies.

A trusted business partner in the field of Medical Device Regulatory Affairs and Clinical Research Management for global MedTech companies.

What we do?

Greetings from 8C Healthcare

Welcome to 8C Healthcare, a Medical Device Research Organization in India with combined strengths in Medical Device Strategic Consulting and Product Life Cycle Management. We are a trusted strategic partner to the MedTech community focused towards advancement of medical technology from ‘CONCEPT to CLINICAL USE’ by addressing design and development challenges, fulfilling quality objectives and achieving regulatory milestones with due respect to Cost, Time and Quality.

8C Healthcare provides extensive strategic solutions for New Product Development, Iterative Clinical Development, Clinical Research Management, Regulatory Affairs, Quality Management System and Trainings for global medical device companies in India and abroad.

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Years in MedTech

Clients in 5 Continents

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Clinical Follow-ups

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Physicians Network

OUR SPECIALTIES

Explore Our Services

8C Healthcare provides end-to-end strategic solutions for New Product Development, Iterative Clinical Development, Clinical Research Management, Regulatory Affairs, Quality Management System and Training services for global medical device companies in India and abroad.

Clinical Trial Management

8C Healthcare offers high quality integrated clinical research management services to our clients who intend to conduct clinical studies for innovative medical devices in compliance with Good Clinical Practices (GCP).

Regulatory Affairs

Medical device Regulatory Affairs consulting is one of the key services provided by 8C Healthcare. We provide regulatory services in all the major medical device markets including US, EU, Canada, Australia and India.

QMS Implementation

At 8C Healthcare, we understand that 'quality' applies to the whole organization and there by goes beyond the product itself. Hence, building a pertinent QMS, implementing it and confirming continuous improvements throughout the product lifecycle is significant.

Trainings

Having a good understanding of the medical device regulations & harmonized standards is a must for every medical device organization and its staff.

India - Import License

The Indian government had recently laid a significant overhaul of its system for regulating medical devices and IVDs. India’s new Medical Device Rules 2017 and its amendments had introduced more formalized regulatory requirements compared to the country’s earlier system.

Our Happy Clients

A huge THANK YOU to the entire 8C healthcare team! Great teamwork, great spirit… leading to exceeding expectations. Please keep up the good work! Best Regards, Michel

Michel Vanbrabant, CEO, iSTAR Medical

When look back at the activities that contributed to the successful outcome of our company being sold, the execution of our first in man trial in India, under your guidance, was a very important contribution. If it were not for your time, focus and expertise, I’m certain that the recent acquisition would not have happened

John Marinchak, CCO, Adhesys Medical Inc.

The 8C team has supported us building out our Quality Management System. Sravan has always been very responsive, quick with turnarounds on requirements and clear in his communication. Look forward to working with them in the future

Rushabh Mehta, Co-Founder & CEO, Digipath Solutions