PTC Introduces PLM Solution for the Medical Device Industry

Windchill® Medical Device Template Enhances FDA Regulatory Compliance Capabilities
NEEDHAM, MA. - March 01, 2005 - PTC (Nasdaq: PMTC), the Product Development Company™, today announced the general availability of the PTC Medical Device Template, combining leading, industry specific capability and consulting expertise. Built on top of Windchill® PDMLink™, 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

"Through the control and management of product and product-related information, PLM solutions can maximize the value of R&D investment, accelerate products through the stages of ideation to commercialization, mitigate cost pressure from the market and internally by streamlining processes and sharing intellectual property, and reduce the burden of regulatory compliance and reporting," said Bruce Hudson, Meta Group.

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.

About PTC Solutions for Medical Products
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.

About PTC
PTC (Nasdaq: PMTC) provides leading Product Lifecycle Management (PLM) software solutions to more than 35,000 companies worldwide. PTC customers include many of the world's most innovative manufacturing companies in the aerospace & defense, automotive, consumer, electronics & high technology, industrial equipment and medical products industries. PTC is included in the S&P 500 and Russell 2000 indices
www.ptc.com




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