> Medical Device Regulatory Consulting Company in Saudi Arabia | Operon Strategist
Welcome to Operon Strategist

Medical Device Project Consulting for Saudi Arabia

We are one of the leading medical device, IVD project and regulatory consulting company in Saudi Arabia, Middle East. Our comprehensive range of services includes turnkey project management, ISO system implementation, training, licensing, regulatory approvals, and certifications tailored to the KSA and Middle Eastern markets.

Leading Medical Device Consultant for Saudi Arabia and the Middle East

Operon Strategist is a regulatory consultation company for medical device manufacturing businesses. We are one of the best consultant companies in KSA for medical device business setup. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. We provide clients with customized solutions to manufacturers looking to set up a world-class manufacturing unit.

Our team has expertise in Medical Device Marketing Authorization (MDMA) registrations for SFDA. We have a reputed client base in Middle Eastern countries.

We also provide medical device consultation for IndiaSouth AfricaEgypt, the USA, the UK, Costa RicaOman, and Iran. For free consultation Contact us now.

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Get in Touch for your medical device consulting enquiries

FDA, CDSCO and CE.

Medical Device Regulatory Consulting Services For RiyadH, KSA

sfda
SFDA Registration
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MANUFACTURING FACILITY
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FDA 510k
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CLEAN ROOM GUIDANCE
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CE MARKING
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ISO 13485

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”
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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”
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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.
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Dr Apurv Patwardhan - Director
Australian Orthopedic Pvt. Ltd, India

What Our Client Says

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