艾昆纬-动态数据馈送灵活的工作流程：QARA在医疗器械监管中的未来（英）

White PaperDynamic Data Feeding Flexible Workflows: The Future of QARA in Medical Device Regulation ANUSHA GANGADHARA, Associate Director, QARA Product Management, IQVIATable of contentsIntroduction 1The regulatory explosion in MedTech 1Quality implications 2Building a dynamic data strategy: The QARA AI agent 5Current challenges to using a QARA AI agent 7Conclusion 8 iqvia.com | 1The medical device industry stands at a critical inflection point. Traditional Quality Assurance and Regulatory Affairs (QARA) processes — built on static datasets — no longer suffice in an environment characterized by accelerating innovation, evolving regulations and real-time data requirements. This white paper examines the imperative shift toward dynamic data systems that enable agile decision-making, predictive compliance and continuous alignment with global regulatory standards.The regulatory explosion in MedTechThe past five years (2020-2024) have witnessed an unprecedented surge in medical device regulations globally. This regulatory proliferation includes 15+ landmark regulations, 60+ major guidelines, 100+ technical amendments, and 20+ global and regional harmonization alignments emerging in rapid succession.Primary markets have undergone significant overhauls, with patient safety concerns triggering cascading effects across regulations affecting both new product launches and existing market approvals. Meanwhile, emerging markets like India and Brazil are revamping their regulatory frameworks to align with global standards.The burden of conforming to these rapidly changing requirements falls squarely on quality and regulatory processes, ultimately affecting commercialization timelines and costs. Organizations’ ability to manage these changes across various countries, technology types and risk classifications has become a critical differentiator in the marketplace.Introduction2 | Dynamic Data Feeding Flexible Workflows: The Future of QARA in Medical Device RegulationQuality implicationsAs figure 2 shows below, quality assurance requirements — mandated by most regulatory agencies as part of technical documentation — have similarly expanded. ISO 13485, the most common quality management standard, has undergone significant updates driven by key regulatory releases worldwide.These updates introduce complexities throughout the product lifecycle and necessitate substantial changes to standard operating procedures and planning processes. The continuous release of new requirements demands an intelligent framework capable of recognizing, filtering, classifying, assessing impact and translating changes into actionable workflows.Note that India and Brazil (not included in the graph) are in the process of revamping complete systems and frameworks to match the global regulations and governance, adding to the global numbers.JP: RevisedPMD act — PMS andcybersecurityJP: Advancedtherapy:AcceleratedpathwaysJP: Acceptanceof Real-worldEvidence (RWE)JP: SaMDguidelines forAI/ML d