Medical Device Consultant | Regulatory Consulting | ISO 13485 Consulting

About Us

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.

Latest Blog

OCTOBER 19, 2018

FDA Updated Premarket...

The Food and Drug Administration (FDA) updated premarket cybersecurity guidance to the...

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OCTOBER 15, 2018

Ultimate Guide on FDA QSR...

The medical device industry in the US is highly regulated, as medical product supplied...

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OCTOBER 13, 2018

Final guidance on medical device...

In association with the safety and efficacy of the applicant’s device, the FDA will...

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OCTOBER 11, 2018

Faster access been given to Indian...

The Indian medical device sector has been observed an increased interest from the MNCs...

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We provide a complete turnkey solution to manufacturers looking to set up a world-class manufacturing unit.

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