The PTC Medical Device Template is designed to help users in the medical device and equipment industry improve time-to-market, satisfy complex FDA regulations, lower regulatory compliance costs, and reduce the time needed to obtain regulatory approval. Incorporating Windchill PDMLink, PTC features data control of electronic records with traceability, global scalability for the extended supply chain, user-authenticated electronic signature with document and process traceability, and a streamlined change management process. To help engineers in the medical device and equipment industry overcome challenges surrounding shortening product lifecycles, the need for more rapid product development, and increased regulatory requirements, the software automates the control of the product data and development process. The software is designed to help engineers drive product innovation, manage product development processes, and comply with regulatory codes relating to data integrity requirements and Quality System Regulation (QSR) governing manufacturing process controls. Furthermore, the software can report functionality to meet the demands of audit requests, offer data collection support critical to design and delivery, and generate process control with workflow for Corrective and Preventative Action (CAPA).
ADVERTISEMENT