About
Stocked with knowledge on Global Medical Devices Regulatory Affairs, we are well equipped to assist with the development and commercialization of Medical Devices hailing from nascent stages (TRL 1-3) to advanced stages (TRL 7-9).
Extensive Regulatory experience of the development and commercialization of more than 500 Medical Devices (implantable, non-implantable, in-vitro diagnostic devices) ranging across varied Risk Classifications.
Paired with expertise on Development of Medical Devices and Quality with engineering and associated regulatory aspects, the combination is guaranteed to be a formidable asset for all your MedTech regulatory requirements.
Meet the Team
&
Collaborators
Nipun Pathak, Director & Head
Regulatory Affairs, Quality Assurance, and MedTech Development
A post-graduate in Pharmaceutical Sciences from Jamia Hamdard University, New Delhi backed by 11+ years extensive experience in Medical Device Industry for indigenously manufactured and imported medical devices (India) specializing in Regulatory Affairs, and assist in Quality and Supply Chain Solutions in India.
Previous associations with Johnson & Johnson, Baxter, Zimmer Biomet, and Indian Institute of Technology (IIT) Delhi in various individual and leadership roles encompassing Administration, CSR activities apart from core Regulatory Affairs profile.
Sanket Khandelwal, Director R&D
Vadanya Scientific
Sanket is a graduate of the Indian Institute of Technology (IIT) Madras and Purdue University (USA). He has over 14 years of technical leadership and hands-on experience in medical device Systems and Software Development in California, working with companies like Medtronic and Given Imaging.
In his past roles, Sanket was responsible for leading cross-functional globally distributed product teams located in USA, Ireland and Israel. Throughout his career, Sanket has led the development of 8+ medical systems and software products commercialized in global markets.
(Retd.) Sqn. Ldr. Nishtha Pathak
Supply Chain Solutions
(Retd.) Sqn. Ldr. Nishtha Pathak has had a happening career. She started as a graduate in Pharma from Delhi and rose (literally) to heights to be a Squadron Leader in the Indian Air Force. With her expertise on Supply Chain Solutions, we are ready to take the MedTech scenario in India, head-on. Nishtha has more than 10 years of experience in Supply Chain Solutions and is well versed with the evolving MedTech environment in India.
More Collaborators details coming soon
Watch this space for more details
SERVICES
Development of Medical Devices
Assistance in Development of Medical Devices and concurrent communication of Regulations at the developmental period
Support on Medical Device Clinical Investigation in India
Guidance on Ethical documentation and Licensing in Form MD-13 and Form MD-23/ Form MD-25 for conducting Medical Device Clinical Investigations in India
Licensing for imported Medical Devices
Guidance on import requirements and Licensing in Form MD-15 as per Medical Device Rules, 2017
Supply Chain Assistance
Apt support to Supply Chain Systems for efficient logistics and Customs Clearance especially for imported devices
Regulatory Strategy and Pathway
Gap Assessment and Communication of Regulatory Strategy and Pathway for swift and efficient Speed-to-Market
Licensing for indigenously manufactured Medical Devices
Licensing in Form MD-8/9 with assistance on Device Development and Quality Management System
Review and Liaison
Review of Technical Documentation and Liaison with Regulators for expedited approvals
Indian Agent Support
Indian Agent services of License maintenance and retention