The Post-Market Surveillance (PMS) process for such Medical Devices is carried out under the Post-Market Surveillance Plan. In accordance with this procedure, methods acquire relevant and new production and post-production information to evaluate possible early warning signs of design and quality problems, emerging problems or safety signals, and to assign action items required throughout the life of the product. PMS data for Medical Products includes internal, external and market-based sources of active data analysis as defined in the PMS plan.