Operon Strategist

Regulatory expertise for medical device manufacturers worldwide

Operon Strategist provides turnkey regulatory solutions to medical device manufacturers, importers, and service providers. Their team of experts helps clients comply with regulations in countries such as the USA, Costa Rica, the UK, Oman, South Africa, Saudi Arabia, Egypt, and Iran. With cumulative years of experience, they offer services like FDA 510(k) approval, CE certification, CDSCO registration, import licensing, manufacturing license, and more. These solutions enable clients to achieve country-specific quality and regulatory compliance. Operon Strategist's expertise is demonstrated by their proven track record of satisfying customers and partners. The company collaborates with world-class companies and personalities in the field of medical device regulatory consulting.