Rigorous Device Testing. Globally Accepted Results.
Amritt creates and fosters productive relationships for medical device manufacturers with India’s best matched CROs for your specific needs.
Why India for Medical Device Testing?
World-Class Testing Infrastructure
For medical device manufacturers in the U.S. and Europe, getting to market requires biocompatibility and safety data that is robust and auditable. Companies in India have built a sophisticated testing ecosystem that delivers exactly that.
The question is no longer whether Indian CROs can produce credible device testing data. The question is whether your team knows how to vet the right lab and navigate the process without costly missteps. That is where Amritt adds ongoing value, from start to finish.
What Do You Get When You Work Through Amritt?
Selecting a testing laboratory involves more than comparing capabilities or pricing. Laboratories differ in regulatory experience, project management, communication, scheduling reliability, documentation quality, and familiarity with different classes of medical devices. Amritt helps clients evaluate these differences before they become expensive problems. Finding the right CRO and managing the relationship effectively is important, and can be handled by Amritt.
Ready to move your device testing forward? Before you select a testing supplier, speak with the Amritt team for a no-obligation consultation.
We will honestly assess your testing needs, match you to the right facility, and tell you what to expect on cost and timeline.
What Device Types Do Indian CROs Support?
Indian CROs are experienced across a wide spectrum of medical devices, including:
By Specialty:
- Cardiovascular devices
- Gastrointestinal devices
- Genitourinary devices
- Neurological devices
- Dental devices
- Integumentary implants
- Therapeutic devices
- Orthopedic devices
By Body Interaction:
- Implanted devices – in tissue, bones, or the cardiovascular system
- Surface devices – intact skin, mucosal membrane, or breached/compromised surfaces
- Externally communicating devices – in contact with blood, tissue, bone, and dentin
What Do Biocompatibility Studies Cover?
Indian CROs are capable of studying biological effect categories – acute systemic toxicity, carcinogenicity, chronic toxicity, cytotoxicity, genotoxicity, hemocompatibility, implantation, irritation, pyrogenicity, sensitization, and subacute toxicity. Studies cover contact durations ranging from less than 24 hours to 30 days or more, and include physical and chemical characterization of device materials. The studies are conducted in accordance with ISO 10993. Indian CROs in our network provide auditable data packages designed for submission to the U.S. FDA, EMA, and India’s CDSCO.
5 Factors That Can Help You Identify Strong Testing Partners
- Experience with devices similar to yours
- Proven regulatory documentation and quality systems
- Clear project management and responsive communication
- Ability to adapt when unexpected issues arise
- Realistic timelines and transparent pricing
Drawing on more than two decades of helping Western companies work successfully in India, Amritt understands that successful testing depends as much on selecting the right partner and managing execution as on technical capability.
Does the U.S. FDA accept medical device testing data generated by Indian CROs?
Yes. The U.S. FDA accepts biocompatibility and safety data from international laboratories, provided the studies strictly adhere to Good Laboratory Practices (GLP) and follow the ISO 10993 framework. Amritt helps ensure that your selected Indian CRO maintains the precise documentation and auditable quality systems required for successful Western regulatory submissions.
How does Amritt protect our intellectual property (IP) when working with foreign laboratories?
IP protection is a core pillar of our oversight. We reject suppliers who don’t have good I.P. practices. You can ask the foreign companies to sign your own robust non-disclosure agreements (NDAs) and clear chain-of-custody protocols before any proprietary device materials, specifications, or data packages are transferred to a testing facility.
I want more information. What should I do?
Before you select a testing supplier, speak with the Amritt team for a no-obligation consultation. We will honestly assess your testing needs, match you to the right facility, and tell you what to expect on cost and timeline.
Last updated: July 22nd, 2026