Pre-Configured, Out-of-the-Box Best Practices
Windchill provides industry leading Product Lifecycle Management (PLM) and Quality Management System (QMS) capabilities in one system to accelerate product innovation, maximize product profitability and reduce compliance cost. PTC’s Medical Device Industry Value-Ready Deployment™ (VRD) is a set of pre-configured, out-of-the-box best practices 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.
The VRD includes pre-defined configurations, training, getting started guides and a validation accelerator package. The VRD is designed to get medical device manufacturing companies up and running quickly with proactive high-quality, well-controlled, fully compliant and traceable product development processes.
Best practice processes offered in the Value-Ready Deployment include:
- Design Control
- Document Control
- Nonconformance Management
- Customer Experience Management (CEM)
- Corrective and Preventive Action (CAPA)
- Risk and Reliability Management
- Audit Management
- Unique Device Identification (UDI)
PTC’s Medical Device Industry Value-Ready Deployment includes a Validation Accelerator Pack for PTC Windchill to assist in the software’s compliance with FDA regulations for the design and development of safe, effective medical devices.
Contact us today to discuss our value-ready deployment.