ZPLM for Medical Device Manufacturers

New Product Introduction

Visibility, Control and Traceability requirements of New Product Introduction process for medical devices require a fundamentally different kind of PLM solution. Z PLM is ideally designed with exceptional process and product information management capabilities that emphasize closed loop control, visibility and traceability of all processes and product information.

Product Compliance (CE, EU MDR, RoHS and more..)

Achieving and demonstrating compliance to regional regulatory requirements can tax even the most well equipped organizations. Z PLM offers extensive coverage and capabilities to make it easy for medical device organizations of all types or achieve compliance as part of the product lifecycle management process. Z PLM offers rich product information and process management coverage for compliance requirements related to EU MDR, CE, RoHS and related regulatory frameworks.

Engineering and Manufacturing Change Management

Ability to coordinate engineering and manufacturing changes effectively across engineering, manufacturing and the supply chain is essential to ensure traceability, control and compliance. Z PLM is an ideal solution for implementing the engineering and manufacturing change process cross-functionally as well as for connecting all the systems (Design PLM, ERP, Supply Chain and Manufacturing Execution systems) that play a role in Engineering and Manufacturing Change Management.

Continuous Improvement Processes

Medical devices have a long life in the field. Ability to continuously improve machines that are on the field leads to improved uptime, availability, and higher customer service levels.  Z PLM has out of the box cross-functional process templates for product/process improvement requestscustomer complaintswarranty requestsreturn materialscorrective action requestsnon-conformances and deviations. In addition, Z PLM supports different types of root cause analyses as part of continuous improvement processes.