PLM & Requirements Management (RM) in Ensuring Compliance across the Lifecycle

Production Innovation Conference November 17-18, 2015 Boston, MA
Date: November 18, 2015 at 2:55 pm Room 1
Presented by Laurence Sampson, COO, Swan Valley Medical & Medical Device Expert for Polarion Software

As is the case in most industries these days, there is a heavy regulatory component within medical device manufacturing. Effective regulatory change management and compliant response across a multiple-team operated company is challenging and requires heightened transparency and collaboration. Laurence (Larry) Sampson joins PI Boston to discuss the two-part deployment of PLM and RM in remaining consistently compliant.

  • Deploying PLM to tackle challenges in engineering change orders, compliance and quality management
  • Why cloud PLM?
  • Integrating PLM with existing enterprise tools
  • Integrating other processes into PLM including CAPA, Quality and Post-market ops
  • Deploying RM to offer flexibility in business software development
  • Authoring, linking and tracking requirements effectively
  • Extracting ideas from PLM's documents
  • Why not integrate PLM and RM?
  • What has RM meant for traceability and collaboration across the lifecycle?