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Leading medical device companies around the world rely on PTC Windchill® to provide Product Lifecycle Management (PLM) and Quality Management System (QMS) capabilities in one system. PTC Windchill synchronizes business processes, product data and content management across enterprise functions and locations giving medical device companies greater advantage in today’s highly regulated global environment.

PTC’s Medical Device Industry Value-Ready Deployment™ (VRD) is a set of pre-configured, out-of-the-box best practice processes to help medical device companies build in product and process quality using PTC Windchill. It maximizes patient safety and efficacy while following the ISO 13485 standard, harmonized with the FDA TPLC and 21 CFR Part 820 regulations. This solution can be deployed in the Cloud as a SaaS-based offering.

PTC’s VRD is designed to get medical device companies up and running quickly with proactive high-quality, well-controlled, fully compliant and traceable product development processes. Best practice processes offered, include:

  • Design Control
  • Document Control
  • Nonconformance Management (NC)
  • Customer Experience Management (CEM)
  • Corrective and Preventive Action (CAPA)
  • Risk and Reliability Management
  • Audit Management
  • Unique Device Identification (UDI)

By centralizing product data and processes, streamlining cross functional change management and harmonizing enterprise functions like engineering, manufacturing and quality management within one system, PTC is leading the way in helping medical device companies meet FDA standards in the “Case for Quality” initiative, accelerate product innovation, maximize product profitability and reduce compliance cost.

USDM’s Validation Accelerator Packs (VAPs) for PLM platforms, including PTC Windchill, are a complete set of validation document templates that enable customers to significantly reduce validation time and cost, as well as reduce implementation time and improve system performance. PTC’s Medical Device Industry VRD supports USDM’s Validation Accelerator Pack for PTC Windchill to assist customers in validating the PTC solution’s compliance with FDA regulations for the design and development of safe and effective medical devices.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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