Turnkey Project Consultants

 Set up a world-class manufacturing plant in Oman with expert facility layout design consulting. Ensure compliance with US FDA, CE Marking, ISO 13485, SFDA, and GMP standards. From workflow optimization and cleanroom-ready areas to regulatory approvals, Operon Strategist delivers efficient, safe, and scalable medical device facility layouts for global market success. Read More

 Discover how to successfully complete medical device registration in Oman with our 2025 step-by-step guide. Learn about classification, documentation requirements, approval timelines, and license validity under DGPA&DC’s notification system. Ensure faster approvals with expert regulatory guidance, authorized representative support, and ISO 13485 compliance from Operon Strategist. Read More

 Expand your medical device business in Brazil with Operon Strategist’s ANVISA Medical Device Registration consulting services . We assist with device classification, B-GMP compliance, INMETRO certification, and Brazilian Registration Holder (BRH) support for smooth market entry. Contact us today! Do you want me to also create multiple short variations (for platforms like Reddit, Scoop.it, Mix, etc.) to boost CTR and avoid duplicate content issues? Read More

UKCA Marking is mandatory for medical devices and IVDs sold in Great Britain, replacing CE marking after Brexit. Algerian manufacturers must comply with UK MDR 2002, prepare technical documentation, and register with MHRA. Operon Strategist guides companies through conformity assessment, QMS alignment, and UK Responsible Person (UKRP) appointment. This ensures smooth regulatory compliance and faster market entry into the UK. Read More

  The Medical Device Single Audit Program (MDSAP) allows a single audit to meet regulatory requirements across multiple countries, including the USA, Canada, Brazil, Japan, and Australia. MDSAP certification streamlines compliance, reduces audit costs, and improves global market access. Operon Strategist helps manufacturers prepare, implement, and succeed in MDSAP certification. Our structured approach ensures efficient audits, ISO 13485 alignment, and faster international market entry. Read More

 Algerian medical device and IVD manufacturers must obtain FDA 510(k) clearance to sell products in the U.S. market. This clearance ensures devices are substantially equivalent to legally marketed devices in the United States. Operon Strategist assists with device classification, technical documentation, and FDA submission management. Our support reduces delays, ensures compliance, and accelerates market entry for Algerian companies. Read More

 Algerian medical device and IVD manufacturers must secure SFDA approval to sell their products in Saudi Arabia. The approval confirms compliance with Saudi safety and quality standards. Operon Strategist assists with MDMA licensing, technical documentation, and risk management. This helps manufacturers enter the Saudi market faster and with confidence. Read More

 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