Medical Device Consulting | Regulatory Consulting | ISO 13485 Consulting

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.

Latest Blog

NOVEMBER 3, 2018

New FDA Guidance Will It Boost...

Implement new technologies such as the cloud, mobility, Big Data, and the Internet of...

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OCTOBER 30, 2018

ULTIMATE GUIDE ON MEDICAL DEVICE...

This is the most comprehensive guide for every manufacturer who wants to the medical...

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OCTOBER 28, 2018

Final Orders on 6 Medical Device...

A set of final orders issued by the US Food and Drug Administration’s Center for...

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OCTOBER 19, 2018

FDA Updated Premarket...

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

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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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