Windchill Quality Management Solutions
Using the PTC Medical Device Suite
The PTC medical device suite allows Windchill customers to meet the processes required by FDA quality system regulation (QSR) and ISO 13485:2016. These processes are available in three groupings of modules, which are pre-configured best practice processes based on PTC’s experience with customers in the medical device industry vertical. These groupings can be deployed together or independently.
The PTC medical device suite consists of three best practice module groupings:
• Medical Device QMS — Document Control
• Medical Device QMS Design Control
• Medical Device QMS Surveillance and Corrective Action
This installer installs the bundle of these three modules – CAPA, NC and CEM.
◦ Corrective and Preventive Action (CAPA): Pre-configured best practice module with multiple action capability. Initiate, evaluate, assign, monitor, review, and approve corrective and preventive actions in a formal manner.
◦ Nonconformance Management: Pre-configured best practice module with split lot disposition. Record, process, manage, and track nonconformance reports, variances, deviations, exceptions, and other quality events related to product manufacturing and processing. A nonconformance occurs when a product, manufacturing material, process, document, or other item does not conform to specifications.
◦ Customer Experience Management (CEM): Pre-configured best practice module with post-market surveillance and regulatory reporting capability. Collect, document, track, trend, and report product quality issues that are recorded by customers as customer experiences.
Additional Modules
Windchill supports additional quality solutions that allow companies to do the following:
• The Windchill Regulatory Hub: Provides an integrated environment within the Windchill PLM system for creating, managing and tracking regulatory submissions related to an organizations products. The Regulatory Hub provides a framework enabling partners and customers to build their own regulatory submission apps to meet their business and market needs. This framework provides customers the flexibility to add and update regulatory submission applications to meet the ever changing regulatory and product landscape without the need of a Windchill update.
• The Windchill Audit Management Process: It allows companies to perform internal and external audits of company and supplier processes as required in ISO 9001. This module allows for the creation and storage of Master Audit Checklists. Additionally, results of the audits are stored at the individual criteria or question level so they can be compared year over year.
• Unique Device Identification (UDI): It is a specific solution for medical device industries which you can use to capture the UDI superset information. This module works with Regulatory Hub, a place, where all the UDI superset data can reside and be used to create geography specific submissions.
Additional Information
For a general overview, including information about quality utilities, see
Windchill Quality Management Navigation.