Windchill Quality 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 space. These groupings can be deployed together or independently. Additionally, they are offered with a Value-Ready Deployment (VRD) from our Global Services Organization (GSO).
The PTC medical device suite consists of three best practice module groupings:
• Medical Device QMS Base — 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:
• Unique Device Identification (UDI): Create unique device identifiers for medical devices and device packages, and submit the identifiers to the Food and Drug Administration (FDA) to comply with medical device regulations.
Additional Information
For a general overview, including information about quality utilities, see
Windchill Quality Solutions Navigation.