This forward-looking discussion dives into how AI is transforming validation workflows in the medical device space. Discover how companies are using machine learning and automation to drive speed, accuracy, and regulatory compliance—all without compromising quality. Tune in for actionable insights that will prepare you to integrate digital solutions into your validation process. What You’ll Gain: […]
Taylor DieringerSenior Staff Quality Engineer – Risk Management iRhythm Technologies, Inc. In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance. A clear, intentional structure supports traceability, aligns with ISO 14971:2019, and enables effective risk control. This article explores three common structures for hazard analysis and […]
Anthony Grilli, CEO & Owner, FOCUS Laboratories
Presented by: Ritam Priya, Consultant, MDRQ ConsultingManufacturers (including software developers) need to gather objective evidence of performance, safety and efficacy to support both their premarket authorization/registration in different markets and postmarket changes. Regulatory requirements are defined by different regulators for product compliance and different committees like ISO, AAMI and IEC that develop standards to help […]
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