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
Let’s Get Started
Regulatory Approvals
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CDSCO Import License
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CDSCO Manufacturing License
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FDA 510(k)
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CE Marking
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Design & Development Documentation
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ISO 13485 Certification Consultant
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MDSAP Consultation
Turnkey Project Consulting
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Manufacturing Facility Designing
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Clean Room Guidance
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Primary Packaing Project & ISO 15378
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Validation Documentation
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Medical Devices Project Reports
Let’s Get Started
Regulatory Approvals
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FDA 510(k)
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CDSCO Registrations
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CDSCO Import License
-
CDSCO Manufacturing License
-
CE Marking
-
ISO 13485 Certification Consultant
Turnkey Project Consultants
-
Medical Devices Project Reports
-
Primary Packaing Project & ISO 15378
-
Manufacturing Facility Designing
-
Validation Documentation
-
Design & Development Documentation
-
MDSAP Consultation
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, Algeria, Brazil and Iran. Contact us now for a free consultation.
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Get in Touch for your medical device consulting enquiries
FDA, CDSCO and CE.
Medical Device Regulatory Consulting Services
CDSCO MFG. LICENSE
CDSCO IMPORT LICENSE
CE MARKING
US FDA 510(k)
SFDA REGISTRATION
OMAN REGISTRATION
EDA REGISTRATION
SAHPRA REGISTRATION
ISO 13485
MFG. FACILITY
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”
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”
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.
Dr Apurv Patwardhan – Director
Australian Orthopedic Pvt. Ltd, India
More Testimonials
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