Medical Devices
End-to-End Testing Services to Support Compliance, Safety, and Market Access.
Industry Focus
Integrated Biocompatibility and Safety Assessment Testing to Meet Global Regulatory Requirements
We help develop an appropriate biological evaluation program for assessing the safety of medical devices as per the latest ISO 10993 standards, FDA guidance document and other relevant guidelines, while performing all studies in compliance with GLP and ISO 17025 to ensure worldwide acceptability. Our medical device testing team has an accumulated experience of 100+ years in biological safety assessment, and biocompatibility testing strategy.
Adgyl Lifesciences is your ideal partner for providing medical device testing services, including data that can be used for 510(k) submissions and to various other regulatory and notified bodies. We are also FDA ASCA-accredited for biocompatibility testing of medical devices.
Core capabilities
- Cytotoxicity
- Sensitisation tests
- Irritation tests
- Systemic toxicity
- Implantation tests
- Hemocompatibility
- Genotoxicity
- Ocular biocompatibility
Regulatory Credentials
Regulatory & Quality Credentials
- First GLP-Accredited in India
We are the first GLP-accredited laboratory in India and has been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND/NDA packages.
- Certified Quality Standards
Our vivarium was the first to have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 2001 and all animal study protocols are reviewed and approved by the Institutional Animal Ethics Committee (IAEC), which is equivalent to Institutional Animal Care and Use Committee (IACUC).
- Regulatory-Ready SEND Data
We deliver validated, submissionready SEND datasets delivered via the FDA-required Submit™ platform
Proven Experience
Established Expertise
With over 1100 clients and 30+ years of experience in conducting drug development studies. We are proud of our strong track record of regulatory submissions and robust historical control data and therefore feels confident in developing and thoroughly assessing the safety profile of your molecules. As an extension of your team, our scientists and technicians will help enable and expedite your research goals, ensuring that your preclinical drug development program provides quality data for key decision-making.
Clients
Years Experience
Global Regulatory Submissions
Investigational New Drug
(IND) packages submitted
- USFDA (US)
- EMA (Europe)
- MHRA (UK)
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- EMA (Europe)
- MHRA (UK)
- USFDA (US)
what people ask
Frequently Asked Questions
What types of testing services do you provide for medical devices?
We offer end-to-end biocompatibility and safety assessment testing services.
Do your studies comply with global regulatory standards?
Yes, all studies are conducted as per ISO 10993 standards, FDA guidance, and other relevant guidelines.
Can you support regulatory submissions?
Yes, we provide data suitable for 510(k) submissions and other regulatory and notified bodies.
Are you accredited for medical device testing?
Yes, we are FDA ASCA-accredited for biocompatibility testing.
Are your studies conducted under quality compliance?
Yes, all testing is performed in compliance with GLP and ISO 17025.
