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

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, and Iran. Contact us now for a free consultation.

operon strategist

Get in Touch for your medical device consulting enquiries

FDA, CDSCO and CE.

Medical Device Regulatory Consulting Services

cdsco
CDSCO IMPORT LICENSE
CDSCO Registration in India
CDSCO REGISTRATION
FDA (510)K
FDA (510)K
manufacturing facility
MANUFACTURING FACILITY
CE Certification
CE MARKING
ISO 13485 service
ISO 13485 - QMS

FEW OF OUR CLIENTS

Testimonials

5/5
“We have had good experience working with OperonStrategist the Medical Device Consultant, The team is experienced, Knowledgeable, result oriented, committed and professional in training and execution of the project, We strongly recommend Operon Strategist for all the services”
operon strategist
Arun Kumar - Director
MP Qatar Trading, Qatar
5/5
“Operon Strategist is an outstanding medical device consulting firms with whom I will do business again and these are my reasons. A true problem solver Very Reliable”
operon strategist
Zak Kouloughi - President
Tradeline Medical Lab, USA
5/5
The Team at Operon Strategist is reliable to work with & they provide excellent regulatory consultancy. They provide round the clock support & all their efforts are much appreciated.
operon strategist
Dr Apurv Patwardhan - Director
Australian Orthopedic Pvt. Ltd, India

What Our Clients Says

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