MedTech Business Review: Specials Magazine

Regulatory frameworks within the life sciences sector are continually evolving; however, their complex legal verbiage often becomes a formidable barrier for industry stakeholders to comply with. They often resort to government websites and industry publications to decipher, but the process remains undoubtedly lengthy. With Globalnorm, the information is at their fingertips. Like an encyclopedia, the company has a centralized knowledge database—namely, ROGER WILLCO and the GLOBALnorm System. By integrating these resources with its consulting services, the company endeavors to streamline the compliance journey for its clients. The GLOBALnorm System seamlessly integrates with ROGER WILLCO, which together serve as a comprehensive hub for regulatory change tracking and standards management. ROGER WILLCO brings to the table advanced real-time monitoring and extensive gap analysis capabilities, enabling users to pinpoint and reconcile any deviations swiftly, safeguarding the integrity of their compliance strategies. Complementing this, the GLOBALnorm System offers access to a comprehensive suite of standards issued by leading international standard-setting bodies, assuring that manufacturers consistently meet the latest criteria stipulated by organisations such as the American National Standards Institute and the European Committee for Standardisation. [CIOS_QUOTES_REPLACE]“Whether a company is searching for new standards for an R&D project or seeking a central repository for existing ones, our user-friendly platform integrates seamlessly with their current workflows via a three-tier model—software as a service license, metadata access and PDF procurement,” says Michael Loerzer, president and managing director of GLOBALNORM. One of GLOBALNORM’s clients, who previously struggled to manage scattered regulatory information across regions, found immense value in ROGER WILLCO, allowing them to focus on specific needs and regions while ensuring timely updates and effortless compliance. For one large, multinational enterprise that previously used a decentralised system, implementing GLOBALNORM’s centralised standards management eliminated redundant purchases, which significantly reduced costs and streamlined employee processes globally. The credit for putting together such a vast database goes to GLOBALNORM’s team of experts dedicated to navigating the intricate world of product compliance. Comprising seasoned professionals who distil and disseminate information in a clear, actionable manner, the team leverages deep industry knowledge. A consultancy enhanced by ISO/IEC 17024-certified product compliance officers and specialists in regulatory affairs, cybersecurity, environmental compliance and electromagnetic compatibility makes GLOBALNORM an invaluable resource across these critical domains. Through its consolidated knowledge base, ROGER WILLCO, GLOBALNORM automatically deliver updates on regulatory and standards changes to medical device manufacturers, ensuring they always remain informed and compliant. This approach is critical in the EU and UK, where vigilant monitoring of updates to the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) is essential. The European Commission’s implementation of the Harmonised Assessment System (HAS) has occasioned delays in the dissemination of harmonised standards, making this proactive update system indispensable. Simultaneously, GLOBALNORM leverages its participation in key organisations like the Deutscher Normenausschuss (DIN), The Radio Equipment Directive Compliance Association (REDCA), Institute of Electrical and Electronics Engineers (IEEE) Product Safety Engineering Society (PSES) and others.