Welcome to Operon Strategist

Medical Device Consulting Services

We are one of the leading medical device regulatory consultant in USA. We offer clients an array of services like turnkey services, system implementation, training, licensing, regulatory approvals, and certifications.

Medical Device Regulatory Consultant

Operon Strategist is a medical device consulting company in the USA that provides regulatory guidance to various manufacturers in the healthcare industry to ensure their strategic development. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. We provide customized solutions to manufacturers looking to set up a world-class manufacturing unit.

Our global presence caters to clients from around the globe and includes everything from small start-ups to the world’s most renowned medical device manufacturers. We have a team of expert medical device consultants whose knowledge and experience help them handle clients both small and large.

Get in Touch for your medical device consulting enquiries

FDA, CE and CDSCO.

Medical Device Regulatory Consulting Services

US FDA 510k
US FDA 510k
CE Marking
CE Marking
CDSCO Medical Device Registration in India
CDSCO Registration

Testimonials

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
“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
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

What Our Client Says

We can successful cater to the international clients to upgrade and monitor their documentation as well as their contract manufacturing sites. The clients rely on us completely for our works and our services, which make us long terms partner with them.
PSS UROLOGY
USA
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