About Us

Operon Strategist is a medical device regulatory consulting company that provides regulatory advisory and guidance to manufacturers in Brazil’s healthcare industry to ensure their strategic development. We serve our clients by offering turnkey services, quality management system implementation, training, licensing, ANVISA regulatory approvals, and certifications. We deliver complete turnkey solutions to manufacturers looking to establish world-class manufacturing units in Brazil. Additionally, we offer customized service packages tailored to each client’s specific requirements. Our global presence serves clients worldwide, from small start-ups to internationally renowned medical device manufacturers. Our team of experts, with extensive knowledge and experience, is equipped to support both small and large-scale projects. As a trusted partner, we are committed to delivering services within budget, on schedule, and to the highest quality standards — consistently exceeding client expectations.

Operon Strategist is owned and partnered with some of the world’s most competent companies and respected professionals in the field of medical device regulatory consulting. With more than 60 cumulative years of experience and over 1,000 services delivered in the medical device regulatory domain, our strategic alliances help clients gain valuable insights into regulatory requirements in Brazil and other countries.

The healthcare industry in Brazil and globally is steadily growing, driven by increased awareness of healthcare options and a willingness to invest in quality healthcare services. To ensure safe and effective products reach the end consumer, manufacturers must establish efficient manufacturing facilities equipped with well-organized quality systems and a skilled workforce — while meeting all ANVISA compliance requirements. Operon Strategist guides such manufacturers in various aspects of regulatory requirements. We also provide medical device consultation for India, Saudi Arabia, the USA, the UK, South Africa, Algeria, Oman, Iran & Egypt. Feel free for contact us.