Quality Management System: Support for eMDR HL7 R2
Product: Windchill
Release: 11.1 F000
Benefit
Allows companies to submit to the FDA on the Electronic Medical Device Reporting (eMDR) R2 release time requirement.
Additional Details
The support for Electronic Medical Device Reporting (eMDR) project has been updated in this release to comply with the new HL7 R2 submission requirements from Food and Drug Administration (FDA). Additional features will be added to Windchill in a future release which will allow companies to fully utilize the new features of R2.
Related Information
For more information, see
eMDR Process Overview.