Welcome to Operon Strategist
Medical Device Registration Consulting
Operon Strategist is the leading medical device regulatory consultant in India, Providing clients with an array of services like turnkey consultation, system implementation, training, licensing, regulatory approvals, and certifications.
32+
No. of Countries Served
150+
Cumulative Years of Experience
950+
No. of Clients Served
3500+
No. of Services
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Operon Strategist
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.
We also provide medical device consultation for the USA, Costa Rica, the UK, Oman, South Africa, Saudi Arabia, Egypt, Germany, Netherlands and Iran. Contact us now for a free consultation.
Get in Touch for your medical device consulting enquiries
FDA, CDSCO and CE.
Medical Device Regulatory Consulting Services
FEW OF OUR CLIENTS
Testimonials
What Our Clients Says
Medical Device blogs
Checklist for the Grant of Import License in Form MD-15 for Medical Devices Under Medical Devices Rules, 2017
A Complete Medical Device Strategy: Alignment Across the Entire Lifecycle
