Simplify laboratory developed test compliance with Product Lifecycle Management

Siemens Product Lifecycle Management (PLM) for Medical Devices empowers laboratory developed test (LDT) companies to adapt to evolving regulatory landscapes. As the FDA intensifies oversight on LDTs, traditional manual systems struggle to keep pace, creating compliance risks and inefficiencies. Siemens PLM transforms these challenges into opportunities by digitalizing quality management processes, enhancing data quality, streamlining regulatory submissions and accelerating time-to-market. This transition from manual to digital not only facilitates compliance but also drives innovation through improved collaboration and resource optimization.

Achieve superior visibility and traceability

PLM for Medical Devices provides an integrated platform that elevates visibility and traceability across all stages of product development. This holistic solution supports end-to-end product life cycle management, enabling R&D and engineering teams to seamlessly coordinate design processes, regulatory submissions and post-market reporting. By automating design controls and integrating cross-domain data, PLM reduces errors, accelerates decision-making and lowers overall costs.

Break down silos with PLM for streamlined efficiency

PLM for MD enables manufacturers to overcome siloed processes with an integrated approach. Digitalization, design authoring and workflow tools unite to create a truly connected platform that results in low-risk offerings with optimized performance.

PLM for Medical Devices helps in numerous areas, including:

• Design History File (DHF)
• Premarket submissions
• Post-market reporting
• Corrective and preventative actions (CAPA)
• Document management
• Labeling and Unique Device Identification (UDI)

Discover how Siemens PLM empowers LDT companies to navigate compliance seamlessly while driving innovation and reducing risk. Read the ebook to learn more.