CIMdata PLM Industry Summary Online Archive
1 March 2005
Product News
PTC Introduces PLM Solution for the Medical Device Industry
PTC announced the general availability of the PTC Medical Device Template, combining leading, industry specific capability and consulting expertise. Built on top of Windchill® PDMLinkT, this packaged services offering, meets the unique needs of the medical device and equipment industry for improving time-to-market while satisfying complex FDA regulations, lowering regulatory compliance costs and reducing the time needed to obtain regulatory approval.
Innovative medical device and equipment manufacturers are faced with shortening product lifecycles that require faster product development. In addition, these medical device and equipment manufacturers are challenged by the increase in regulations requiring electronic data management, electronic signatures, secure user authentication and traceability. Because of these challenges, there is an emerging industry-wide requirement to fully automate the control of all product data and development processes, within robust and compliant quality systems. PTC now provides an easy-to-adopt solution that enables medical device and equipment manufacturers to drive product innovation, manage key product development processes, and comply with regulatory codes relating to data integrity requirements and Quality System Regulation (QSR) governing manufacturing process controls.
With the PTC Medical Device Template, PTC now offers:
• Data control of all electronic records with complete traceability
• Global scalability for the extended supply chain
• User authenticated electronic signature with document and process traceability
• Streamlined change management process
With the PTC Medical Device Template, customers are able to take advantage of the following benefits:
• Reporting functionality meeting the demands of audit requests
• Data collection support critical to design and delivery: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
• Process control with workflow for Corrective and Preventative Action (CAPA)
"With this offering, PTC is providing a focused service offering for medical device manufacturers to enable them to take advantage of Windchill as a world-class Product Development System while at the same time meeting US FDA requirements. We believe that customers will achieve significant business returns with this solution," said Andrew Rhoades, senior vice president for PTC's Services Portfolio.
PTC solutions for medical products are designed to meet the product lifecycle management requirements of medical device, pharmaceutical, and medical equipment manufacturers. These solutions include product development process and data management, electronic verification and collaboration, authenticated electronic signatures and 3D mechanical design. PTC has over 500 medical products customers, including the top manufacturers across the globe.
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