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Achieve continuous worldwide UDI Compliance
UDI Platform
byp36 GmbH
Solution Types
Extensions and Add-ons
Works with
Industry Cloud, SAP Extension Suite and/or SAP Integration Suite
Benefits and Features
Benefits
Handle the complexity of multiple markets with one platform
Content Packages enable you to use the UDI Platform as a central system for all UDI-related maintenance and submission processes of multiple regulatory authorities. Start to ensure compliance with FDA and EU MDR and add more Content Packages at any time.
Stay compliant to UDI requirements of regulatory authorities worldwide
UDI will be an ongoing process in your company as more regulatory authorities are to follow and existing UDI databases will come up with changes of requirements. We monitor the market requirements and implement changes timely in your cloud solution account to support you in maintaining compliance.
Bridge the gap between operational and regulatory processes
The integration based on SAP technology enables bidirectional data exchange to keep your data governance processes as efficient as possible. Reuse your existing product master data from your SAP ERP systems by sending it to the UDI Platform and then return all information to your SAP Systems.
Benefit from a native SAP integration
Due to its delivery on SAP Business Technology Platform, the UDI Platform natively integrates into your existing hybrid SAP Landscape and thus enables the integration of your operational ERP processes of UDI-related product data 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.
One End-2-End solution for UDI-related processes
Cover the requirements on Unique Device Identification of regulatory agencies around the world with one End-2-End workflow-based UDI data governance and submission solution – fast, flexible and easy to use.
Maintain global UDI compliance
We monitor the market requirements and implement changes timely in your cloud solution account. This allows you to maintain compliance, meet deadlines of regulatory authorities, capture additional requirements, and ensure that pending changes are implemented while the entire UDI Platform is running.
Plans and Pricing
hand with checkmark
All Plans include
Managed UDI Platform
Enhanceable Rules Framework
Customizable Maintenance Processes based on Workflows
Highly customizable User Interfaces
Integration into existing on-premise Processes
Re-Use of existing Master Data
Advanced Reporting for Data and Submission status
UDI Platform Base Package - Small Enterprise
USD
3,010
.00
Per Month
UDI Platform Base Package - Small 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
UDI Platform Base Package - Medium/Large Enterprise
Price upon request
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
Includes unlimited User
Please contact us for a personal quote
FDA Content Package
Price upon request
FDA Content Package
Includes the GUDID data model with all necessary attributes, validation and changeability rules and the submission handling with GUDID
GUDID Data Model with all necessary attributes
Includes all validation and changeability rules
Grace Period-handling
Unlocking Feature
Submission Handling
Includes unlimited User
EUDAMED Content Package
Price upon request
EUDAMED Content Package
Includes the EUDAMED data model with all necessary attributes for MDR/IVDR, validation and changeability rules, the submission handling with EUDAMED
EUDAMED data model and all necessary attributes for MDR/IVDR incl. Basic UDI handling and legacy devices
Includes all validation and changeability rules
Submission handling
Includes unlimited User
Technical Information
The information contained in this section is provided by the publisher.
Solution Types
  • Extensions and Add-ons
Works with
  • Industry Cloud
  • SAP Extension Suite and/or SAP Integration Suite
Publisher
p36 GmbH
p36 is a dynamically growing IT Company located in Bad Hersfeld, Germany. Our business areas provide Software-as-a-Service solutions for the Life Sciences industry with special expertise in regulatory topics as well as Professional Services as SAP Clou...
Publisher Website