Turnkey Project Consultants

 Clean room design is a critical component of medical device manufacturing, ensuring that products are made in a contamination-free environment that meets strict safety and regulatory standards. For medical device manufacturers in Brazil, complying with ANVISA regulations and international standards like ISO 13485 and ISO 14644-1 is essential for maintaining product quality, reducing contamination risks, and achieving successful market approval. At Operon Strategist, we offer expert consulting services tailored to the needs of medical device manufacturers, providing end-to-end support from design conceptualization to validation and regulatory approval. Our services include clean room layout planning, environmental control systems, operational guidelines, and training to ensure that your manufacturing facility operates efficiently and safely. With proven experience in global clean room projects and in-depth knowledge of Brazil’s regulatory landscape, Operon Strategist helps you crea...

 For medical device manufacturers in Brazil, achieving MDSAP (Medical Device Single Audit Program) certification is essential to ensure compliance with ANVISA and gain faster access to global markets. MDSAP allows manufacturers to meet regulatory requirements in multiple countries—including the USA, Canada, Japan, Australia, and Brazil—through a single, streamlined audit process. This reduces audit duplication, lowers compliance costs, and strengthens trust among healthcare providers and regulatory bodies. At Operon Strategist, we guide Brazilian medical device companies through every step of the MDSAP certification process, from gap analysis and QMS implementation to audit preparation and documentation submission. Our team of experienced consultants helps you align your quality management system with ISO 13485, prepare for inspections, and confidently achieve certification. With tailored support packages for startups and established manufacturers alike, Operon Strategist ensures y...

Medical device design and development is a crucial process that transforms innovative ideas into safe, effective, and market-ready healthcare products. For medical device manufacturers in Brazil, aligning design efforts with global standards like ISO 13485, ANVISA, and FDA guidelines is essential for ensuring patient safety and regulatory compliance. At Operon Strategist, we provide expert guidance throughout the entire design and development lifecycle—from feasibility studies and risk management to prototyping, verification, and validation. Our structured approach helps manufacturers create devices that meet market demands, improve clinical outcomes, and adhere to strict regulatory frameworks. We also support combination products such as drug-device systems, ensuring robust design controls and quality management practices. With our experience in regulatory strategy, device classification, usability engineering, and QMS setup, Operon Strategist is your trusted partner in bringing innov...

 For Brazilian medical device manufacturers aiming to expand into Saudi Arabia, obtaining SFDA approval is essential to access one of the Middle East’s largest and fastest-growing healthcare markets. At Operon Strategist, we offer expert consulting services to guide you through every stage of the SFDA registration process. From determining your device’s risk classification and preparing technical documentation to appointing a trusted Local Authorized Representative (LAR) and managing post-market surveillance, we ensure a seamless and compliant registration journey. Our team helps reduce delays, improve approval success rates, and navigate complex regulatory requirements efficiently. With over 15 years of global regulatory experience and a proven track record in Middle East market entry, Operon Strategist is your trusted partner for SFDA approval in Saudi Arabia. Get in touch with us today and let’s grow your business together. Read More

 Entering the Brazilian healthcare market can be complex, but with the right regulatory guidance, it becomes much more manageable. At Operon Strategist, we specialize in helping medical device manufacturers navigate the ANVISA registration process, ensuring full compliance with Brazil’s safety, quality, and performance standards. From device classification and technical documentation to Brazilian GMP compliance and INMETRO certification support, our expert team provides end-to-end solutions tailored to your product’s needs. We also assist in appointing a reliable Brazilian Registration Holder (BRH), giving you greater control over your operations and long-term business strategy. Partner with Operon Strategist to gain seamless market access and enhance your product’s credibility in one of Latin America’s fastest-growing healthcare markets. Contact us today to start your journey towards regulatory success in Brazil. Read More

 Operon Strategist offers expert turnkey project consulting for medical device manufacturers in Algeria. From facility design and cleanroom validation to regulatory approvals and staff training, we provide end-to-end solutions ensuring faster setup, cost optimization, and compliance with local and global standards like ISO 13485, US FDA, and EU MDR. Read More

 Operon Strategist offers expert MDSAP consulting services for medical device manufacturers aiming to expand into global markets like the USA, Canada, Brazil, Japan, and Australia. We support you through gap analysis, QMS implementation, audit readiness, and certification to ensure compliance with ISO 13485 and country-specific regulations, helping you unlock faster market access and reduce audit complexities. Read More

 Operon Strategist helps Algerian medical device and IVD manufacturers get FDA 510(k) clearance faster. From device classification to documentation and submission, we simplify the process for smooth entry into the U.S. market. Our team ensures full compliance with FDA regulations, reducing delays and avoiding common pitfalls. Partner with us to expand your business and confidently navigate the U.S. healthcare landscape. Read More

Expand your business in Saudi Arabia with SFDA approval for medical devices and IVDs. Operon Strategist helps Algerian manufacturers with device classification, MDMA submission, e-MDAM platform handling, and post-market compliance to ensure smooth and fast regulatory approval. Get expert guidance today!  Read More