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 adequate 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 Medical Device regulatory requirements.
Meet the Team
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Collaborators
What We Provide?
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