Ensure the Highest Levels of Device Quality and Safety
In the design and development of medical devices, the FDA’s “Case for Quality” calls for manufacturers to ensure the highest levels of device quality and safety throughout product design, manufacture and service. The advanced technology inherent in today’s medical devices and their production means that all aspects of the system–including mechanical, electrical, software, and hardware–must be carefully controlled throughout the product development lifecycle in accordance with strict worldwide regulations and standards.
Windchill provides industry leading Software PLM (Product Lifecycle Management) (PLM) and Windchill Quality Solutions (QMS) capabilities in one system to accelerate product innovation, maximize product profitability and reduce compliance cost. Windchill delivers a “single source of truth” for business processes, product data and content across enterprise functions and locations. Best practice processes for medical device manufacturers are pre-configured in PTC’s Medical Device Industry Value-Ready Deployment™, including:
- 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 Windchill to assist in the software’s compliance with FDA regulations for the design and development of safe, effective medical devices.
Explore the success of PTC Medical Device Industry