Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & 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 a complete turnkey solution to manufacturers looking to set up a world-class manufacturing unit. We also provide customized packages as per the requirements of the client. 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. As a trusted partner to our clients, we strive to provide services within budget, agreed on timeline & to the highest quality standards in order to exceed expectations.

Operon Strategist is owned & partnered with world’s competent companies & renowned personalities in the field of medical device regulatory consulting. With more than 60+ cumulative years of experience, providing 1000+ services in the field of medical device regulatory consulting, Operon Strategist’s strategic alliance with these companies helps the clients in obtaining an insight into the regulations of various countries.

Healthcare industry is steadily growing both in India as well as internationally which can be attributed to raising awareness among people of various healthcare options & people being more open to spending on quality healthcare services. To ensure that safe & effective products reach the end consumer, manufacturers must ensure that they have an efficient manufacturing unit site equipped with a well-organized quality system & skilled workforce. Operon Strategist guides such manufacturers in various aspects of regulatory requirements.

Our Vision & Mission

Operon Strategist aims to provide medical device regulatory consulting services to healthcare industries to ensure a high level of compliance with the good quality product. We do this by following ethical approach, well-grounded training & services with complete experience and expertise to meet the clients need for quality, consistency and time bound services.

Why choose us?


Commitment, responsibility and liability during and after completion of the project.


We are highly educated and are having great experience to handle the smallest & largest projects and at all levels.

Assured confidentiality

As a medical device consultant, we ensure complete confidentiality regarding the project and product process.

Timely Execution

We have dedicated project management team which ensures meticulous planning and always update the stakeholder of the project with their project status reporting

Global Presence

Our global presence caters to clients from around the globe and includes small start-ups to the world’s renowned medical device manufacturers

Our Medical Device Consulting
Expert Team

Anil Chaudhari

CEO (Operon Strategist)

Anand Akerkar

Scientific Advisor  to Ex – US Congressaman Benjamin Gilman

Alan Schwartz

Regulatory Expert

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