Achieve continuous worldwide UDI compliance
UDI Platform is a Unique Device Identification (UDI) governance solution that enables medical device manufacturers to meet UDI requirements of regulatory authorities worldwide. It is built on SAP BTP and part of SAP Industry Cloud. It natively integrates into Hybrid IT landscapes.
By p36 GmbH
Overview
Simplify the complexity of multiple markets with one platform
Content Packages enable you to use our platform as a central system for all UDI-related maintenance and submission processes of multiple regulatory authorities. Ensure compliance with the FDA and EU MDR and add more Content Packages at any time.
Stay compliant with UDI requirements of regulatory authorities worldwide
We monitor the market for new or updated requirements made by regulatory authorities worldwide and update UDI Platform with any changes. This allows you to maintain ongoing UDI compliance.
Bridge the gap between operational and regulatory processes
SAP integration enables bidirectional data exchange to keep your data governance processes as efficient as possible. Reuse your existing product master data from your ERP systems by sending it to UDI Platform and then return all information to your systems.
Details
Solution Type
Extensions and Add-ons
Industry
Life Sciences
Compatibility
Works with
Features
Streamline processes with native SAP integration
Due to its delivery on SAP Business Technology Platform, UDI Platform natively integrates into your existing hybrid IT landscape. As a result, your operational ERP processes of UDI-related product data integrate with regulatory governance and submission processes.
Add Content Packages for global UDI compliance
Content Packages enable you to cover the requirements of multiple regulatory authorities and thus achieve global UDI compliance. The Common Device Model as single-source-of-truth allows you to maintain core attributes of your medical devices once and reuse for submissions to different authorities.
Manage the entire governance lifecycle end-to-end
Meet UDI requirements from regulatory authorities around the world with a single, end-to-end, workflow-based UDI data governance and submission solution – fast, flexible and easy to use.
Plans and pricing
All plans include:
UDI Platform Base Package - Medium/Large Enterprise
UDI Platform Base Backage. Your start with the UDI Platform - get familiar with the platform and its features.
UDI Platform core incl. Common Device Model
Please contact us for a personal quote
Includes unlimited User Price upon request- Has prerequisite
See all pricing details UDI Platform Base Backage. Your start with the UDI Platform - get familiar with the platform and its features.
UDI Platform core incl. Common Device Model
Please contact us for a personal quote
Includes unlimited User USA I FDA (GUDID) Content Package
GUDID Data Model with all necessary attributes
All validation and changeability rules
Grace period handling
Unlocking functionality for critical corrections
Data submission to GUDID database
Includes unlimited User Price upon request- Has prerequisite
See all pricing details GUDID Data Model with all necessary attributes
All validation and changeability rules
Grace period handling
Unlocking functionality for critical corrections
Data submission to GUDID database
Includes unlimited User Europe I EC (EUDAMED) Content Package
EUDAMED Data Model with all necessary attributes for MDR/IVDR
All validation and changeability rules
Includes unlimited User Price upon request- Has prerequisite
See all pricing details EUDAMED Data Model with all necessary attributes for MDR/IVDR
All validation and changeability rules
Includes unlimited User South Korea I MFDS (IMDIS) Content Package
IMDIS Data Model with all necessary attributes
All validation and changeability rules
Data submission to IMDIS database
Includes unlimited User Price upon request- Has prerequisite
See all pricing details IMDIS Data Model with all necessary attributes
All validation and changeability rules
Data submission to IMDIS database
Includes unlimited User
Customer reviews
Technical Information
| Solution Type | Extensions and Add-ons |
| Category | Data and Analytics |
| Industry | Life Sciences |
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The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
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| Globalization |
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| Operations |
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The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
| Security |
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| Compliance |
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| Privacy policy |
SAP's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner. |
Resources
Built on SAP Business Technology Platform
UDI Platform Infographic
UDI Platform Success Story RAUMEDIC AG
UDI Platform Factsheet
UDI Platform Presentation
Publisher
p36 GmbH
p36 is a pioneering technology company specialized in driving cloud innovation for Life Sciences. p36 offers modern cloud solutions supporting companies in the Life Science industry to master regulatory and compliance requirements and advises customers to embark on their digital transformation journey to the cloud.
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