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Pure Global is a medical device regulatory consulting company, accredited under the BSI ISO13485:2016 quality management system. Our experienced team, including many Regulatory Affairs Certification (RAC) holders, leverages deep industry knowledge and international reach to assist our clients in achieving global expansion. Recognized as a leading authority in the regulatory field for medical devices and in vitro diagnostics, we feature a global consulting team proficient in regulatory stipulations and endowed with substantial clinical acumen. Our ISO 13485 accreditation highlights our commitment to delivering high-quality guidance within the intricate international regulatory landscape. The challenge of launching new products into the market can be daunting; however, we are here to provide support. Our broad network encompasses clinical sites and biobanks, which are instrumental in fulfilling your clinical and regulatory requirements. Our wide-ranging service offerings include: Regulatory Support Clinical Trial Management Local Representation Surveillance of Post-Market Activities Testing for Biocompatibility, Packaging, and Sterilization Validation AI & Data Services Market Analysis Updates on Regulatory Changes Clinical Research Documentation Global Distributor Records Certification Management 1. Services Provided by Pure Global to MedTech Companies Pure Global offers an extensive range of specialized services tailored for MedTech companies. These include support for market registration, regulatory compliance, quality assurance, local representation, and clinical assistance. We provide strategic support to navigate the intricacies of regulatory compliance and market penetration, ensuring that products meet international standards and achieve commercial success. 2. How Pure Global Supports Global Market Entry for Companies Pure Global's network of professionals and local representatives, positioned in various international offices, accelerates the process of gaining and maintaining market access. We support our clients through market evaluations, product lifecycle management, and specialized training—essential for entering new markets and sustaining international compliance. 3. Overview of the Global Regulatory Intelligence Platform (GRIP) GRIP is a comprehensive platform that tracks regulatory trends in over 100 countries, providing expert analysis and detailed data on millions of products across 30 regions. It includes information on product classifications, standards, catalog details, and key specifications, enabling companies to stay informed and compliant with global regulatory requirements. 4. Who Benefits from Pure Global's Services? Pure Global's services are designed to cater to the needs of manufacturers of medical devices and in vitro diagnostics, from emerging startups to well-established multinational companies. We provide dynamic regulatory advice for startups, strategic assistance for growing enterprises, and advanced regulatory strategies for multinational corporations, assisting them in navigating regulatory challenges and enhancing their product offerings. 5. Clientele and Impact of Pure Global Pure Global has successfully assisted over 300 clients worldwide, helping them to navigate the challenges related to market access and regulatory compliance. 6. Expertise in Market Access Demonstrated by Pure Global With a record of securing over 1900 global registration certificates, the team at Pure Global exhibits profound expertise and a proven track record in achieving market registrations, ensuring that products meet all necessary regulatory and quality standards for market launch.