Medical Device Consulting

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

Our global presence caters to clients from around the globe & includes small start-ups to world’s renowned medical device manufacturers. We have a team of experts whose knowledge & experience helps them handle clients both small & large.

Our Services

We provide medical device regulatory consulting services for Turnkey Project that includes Facility layout design, Regulatory support for Clean Room,…

We are the medical device consulting, located in more than 6 countries. We cater to the global clients for medical device manufacturing…

Medical Device Regulatory Consulting for Turkey projects of primary packaging material manufacturing along with quality assurance…

Expertise in handling the Drug-Device combination product. As they are strictly regulated & as per quality standards.

Post-Market Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market.

The instruments, equipment and utilities shall run through the adequate qualification/validation life cycle…

We are medical device consultants in India provide complete assistance for registration in more than 125 countries.

With the expertise in regulatory affairs and quality management systems, we monitor facilities…

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Our Valuable Clients

Our Clients Testimonials

“Operon Strategist is an outstadning medica device consulting company with whom I will do business again and these are my resoans.

A true problem solver Very Reliable”


Zak Kouloughli, President Tradeline Medical Lab, USA

“We hired Operon Strategist the medical device consultant as a subject matter expert fot overseeing steriliziation activity by adhering to the protocol and for reviwing results and reports in like with global standards and our requirements for the commercial launch of a product in the global market.”

Rahul Paith, Project Manager
Medtronic, India

“We have had good experience working with Operon Strategist the Medical Device Consultant, The team is experience, Knowledgeable, result oriented, committed and professional in training and execution of the project, We strongly recommand Operon Strategist for all the services”

Arun Kumar, Director/MP
Qatar Trading, Qatar

“The Team Operon Strategist is reliable to work with & they provide excellent medical device regulatory consultancy. They provide round the cloc support & all their efforts are much appreciated.”

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

“The Efforts of Operon Strategist in helping us resolve our various regulatory queiries have been outstanding. There expertise & regulatory knowledge puts them on par with other globally recognize medical device regulatory consultants.”

Manish Jain, CEO
Cilicant Chem Pvt Ltd, India