This white paper explains how Quality Assurance and Regulatory Affairs (QARA) has evolved from a compliance function into a strategic commercial enabler for global MedTech organizations. It outlines three structural challenges—country-specific regulatory requirements, product-specific standards, and prolonged global registration timelines—that delay market access and increase operational risk. The paper presents a target operating model for digitized QARA, integrating QMS, RIM, and regulatory intelligence with commercial objectives. It highlights pragmatic AI use cases in safety surveillance, complaint handling, and regulatory coding that improve speed, consistency, and resource efficiency while preserving human oversight. The paper concludes that commercially aligned, digitized QARA solut

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