• Windchill QMS Foundation (General and Med Device)— Includes the QMS foundation data, Failure Mode, Failure Effects and Harm Hazard. QMS foundation does not include QMS module features of Windchill CAPA, Windchill Nonconformance, Windchill Customer Experience Management, or Windchill Audit. To avail QMS module features, select Windchill QMS Surveillance and Corrective Action (Med Device) as a group based on the business requirement or license features.

• Windchill QMS Surveillance and Corrective Action (Med Device) — Includes the full functionality of QMS. This module supports Windchill CAPA, Windchill Nonconformance, and full capability of Windchill Customer Experience Management. It incorporates predefined templates and processes to support the medical devices industry regulations.

• Windchill Regulatory Master (Med Device) — Includes the full functionality of Windchill Regulatory Master, such as, creating, editing, and viewing a regulatory submission. This module enables users to make regulatory submission to the regulatory agencies and follow-up on the regulatory submission in conjunction with Windchill QMS Foundation.

• Windchill Unique Device Identification (Med Device) — Includes the full functionality of Unique Device Identification (UDI), such as, creating, editing, and viewing a UDI. This module enables users to assign a unique identifier to medical devices in all geographies.