About Us

Operon Strategist is a medical device regulatory consulting company that provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We provide turnkey services spanning from product design and development, and manufacturing unit design up to achieving regulatory approvals at national as well as international levels. 

We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. Our customized packages are designed as per the needs of the client. Our global presence caters to clients from around the globe & includes small start-ups to the world’s renowned medical device manufacturers. The Knowledge and experience of our technically expert team help our client to achieve desired results. Our cost-effective services, timely deliverables, and Quality standards have proven us as a trusted partner for many. We help manufacturers to implement well-designed QMS to ensure safe and effective products for the end users. Operon Strategist guides such manufacturers in various aspects of regulatory requirements. 

We offer worldwide regulatory compliance support to health industry service providers. Spread your wings without any hurdles, get your quote now! 

We also provide medical device consultation for Costa Rica, the UK, Oman, South Africa, Saudi Arabia, the USA, Egypt, Germany the Netherlands and Iran. Contact us now for a free consultation.