Operon Strategist is a group of quality-driven, experienced & committed people, who provide regulatory guidance to medical device manufacturers, importers & medical device service providers. We specialize in providing turnkey solutions & getting regulatory approvals like FDA 510(k), CE certification, CDSCO registration, CDSCO import licensing, CDSCO manufacturing license, and more. 

For more than 12 years we have been serving national as well as international clients for compliance with medical devices regulation. Our regulatory consulting team supports you to achieve country-specific quality and regulatory compliance. Our quality services and proven track record of satisfying customers and partners demonstrate our expertise.     

Operon Strategist is partnered with the world’s competent companies & renowned personalities in the field of medical device regulatory consulting.