Turnkey Project Consultants

 Operon Strategist provides expert medical device validation documentation services in Brazil to ensure compliance with ANVISA, FDA, and ISO 13485 standards. Our team prepares comprehensive process validation protocols, reports, and supporting documentation to guarantee product quality and regulatory adherence. We cover all aspects of validation, including equipment, HVAC, cleaning, packaging, and personnel processes. With Operon Strategist, manufacturers can streamline verification and validation activities, reduce risks, and maintain consistent product quality. Partner with us to ensure your medical device manufacturing processes are fully validated and audit-ready. Read More

 Operon Strategist offers expert turnkey project consulting for medical device manufacturers in Brazil. We provide end-to-end solutions, including facility setup, manufacturing plant layout design, and regulatory compliance with ANVISA. Our services ensure faster market entry, reduced operational risks, and adherence to international quality standards. From post-market support to QMS certification, we manage every stage of your project efficiently. Partner with Operon Strategist to streamline your medical device manufacturing journey in Brazil. Read More

 Planning to launch your medical device in the US? Operon Strategist helps Algerian manufacturers navigate the complex FDA 510(k) submission process with expert regulatory support. From predicate device identification to dossier preparation and FDA liaison, we ensure a faster, compliant market entry into the U.S. medical device sector. Read More

 Discover how to start a surgical bandage manufacturing unit in Algeria. Learn about raw materials, ISO 13485 requirements, and ANPP regulations. Operon Strategist provides complete consulting support, from plant layout design to regulatory dossier preparation, helping Algerian manufacturers achieve faster market entry. Read More