From QSR to QMSR

As medical device regulations continue to evolve, manufacturers face growing pressure to demonstrate complete product traceability, connected quality assurance processes, and inspection-ready evidence across the product lifecycle. The FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) aligns US medical device quality requirements with ISO 13485:2016. This transition places greater emphasis on demonstrating evidence backed by connected data throughout the lifecycle rather than managing isolated documents.

In this webinar, we will explain the practical implications of QMSR and discuss how modern product lifecycle management (PLM) provides the digital foundation for connecting engineering, quality, regulatory, manufacturing, and supplier information into a single traceable product record.

During the session, our experts will cover:

• What has changed from QSR to QMSR, and what has not
• How QMSR shifts expectations for FDA inspection readiness
• Why traceability and connected product data are increasingly important
• The role of PLM in supporting design controls, risk and change management, and quality assurance processes
• A live demonstration of Aras Innovator showing how a connected digital thread helps organizations quickly navigate from a customer complaint through CAPA, engineering change, risk assessment, verification, and validation to product release

Register today to discover how a robust digital thread can help your organization simplify the transition to QMSR, improve FDA inspection readiness, and accelerate quality control across the product lifecycle.