p36.labs recently started their first implementation project for EUDAMED together with a world-leading medical device manufacturer. Right now the client establishes its UDI maintenance processes based on the UDI Platform by p36.labs and integrates the cloud solution into its existing SAP system landscape.
The Go-live for the first phase is planned in October 2019.
The UDI Platform
The UDI Platform is natively built on SAP Cloud Platform, fits into heterogenous IT landscapes (SAP and non-SAP) and provides the complete data governance and submission processes of UDI related Product Master Data.
Content Packages enable medical device manufacturers to cover the requirements of different regulatory authorities, containing the specific data model, data validation rules and the complete handling of exchanging data with the authorities.
Based on the managed service approach and regular market monitoring, software updates are provided whenever required for ensuring continuous UDI compliance.
Read more: https://www.udiplatform.com
New Content Package for EUDAMED
Timely to the start of the implementation project, p36.labs launched their EUDAMED Content Package which is now available besides the FDA GUDID Content Package.
Since EUDAMED data exchange capabilities are not available yet and the date of application for EU MDR in May 2020 is getting closer, the EUDAMED Content Package was released based on the latest available data model definitions and business rules. This enables starting implementation projects right now, resulting in a phased approach for the complete UDI project. The data submission interface to the EUDAMED database will be added as functionality to the EUDAMED Content Package within a later release as soon as the European Commission provides the necessary interface capabilities.
projektraum36 GmbH & CO. KG
Badestube 9
36251 Bad Hersfeld, Germany
Contact:
Phone: +496621 – 7954500
E-Mail: celine.schmidt@projektraum36.de
About p36.labs
p36.labs is a business unit of projektraum36, an SAP Silver Partner focusing on SAP Cloud Platform Solutions with special expertise in Unique Device Identification (UDI) topics since 2012, including consultancy and project management for several Med Tech companies in this area.
Get more information: https://www.p36labs.com/
