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Enhance data traceability with a quality management and compliance framework

Although 90% of medical device manufacturers proactively promote quality, many often overlook cost measurement and lean towards addressing failures rather than preventing them. This has led to thousands of recalls in the U.S. and Europe between 2018 and 2022, and quality process issues persist as a primary cause of recalls. Our Closed Loop Quality and Compliance solutions include data traceability tools that create an integrated digital backbone, centralizing quality data across departments and fostering collaboration. The framework addresses critical aspects of medical device quality and compliance, such as Design Data Management, Product Line Management and Quality Process Management.

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Track quality and compliance with a digital framework

A specialized digital framework is essential to ensure robust quality and compliance data tracking in medical device manufacturing. Utilizing a PLM/ALM (Product Lifecycle Management/Application Lifecycle Management) tool as a digital backbone facilitates comprehensive planning, control and monitoring across all stages, from design and development to manufacturing and post-market surveillance. Our Closed Loop Quality and Compliance tools further enhance this digital transformation by automating document and data flow, offering components unattainable through traditional paper processes. These tools empower users to coordinate multi-disciplinary teams, establish key performance indicators (KPIs) and ensure compliance with regulatory requirements.

Read our ebook and learn how an integrated digital backbone can revolutionize data traceability and quality management in medical device manufacturing.