Achieve Proof of Compliance, Faster
Bridge the gap between fast-paced development, complex quality assurance, and cumbersome proof of compliance.
Siemens PLM Software’s knowledge of industry standards combined with unified Application Lifecycle Management (ALM) capabilities help accelerate innovation for our medical customers, while streamlining quality assurance and automating proof of compliance.
Everything you need to accelerate innovation in one Unified Solution
Connect teams and projects, and improve application development processes with a single, unified solution for requirements, testing, and release.
Automate Risk Management and Compliance
Workflow control of individual work items enables streamlined, interdependent processes
Linking of work items delivers full traceability throughout the lifecycle and across projects
Comprehensive, automated history of all artifacts facilitates proof of compliance - Integrate risk management processes leveraging the medical device template
Automate Your Validation and Verification (V&V):
V&V is supported via comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the lifecycle as well as across projects.
Furthermore, it is supported via review and approval of any work item with electronic signature, combined with uninterrupted traceability starting at the design phase.