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Untertitel, ggf. Kunde,
Ort
UDI Platform
Managed Service on SAP Cloud Platform
Seite 2© projektraum36 GmbH & Co. KG
| 29.01.2019
About Unique Device Identification (UDI)UDI is already mandatory in USA and is part of
EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR)
• UDI helps identifying products (via Label) and publishing product master-data in public databases
Goals
• Improve patient safety
• Improve recall processes
• Improve Market surveillance
Mandatory for all Medical Device Manufacturers
FDA
exa
mp
le
Seite 3© projektraum36 GmbH & Co. KG
| 29.01.2019
5
The global UDI Challenge
Many more UDI
Regulations are in
works
Few Years
Which Authority
demands what
and when?
A Puzzle
Different Data
Models, different
UDI Databases
Different…
Seite 4© projektraum36 GmbH & Co. KG
| 29.01.2019
EU MDR / IVDR Transition Periods
05/2017
EU MDR Effective
EU IVDR Effective
05/2022
EU IVDR
Date of application
05/2020
EU MDR
Date of application
Today
Seite 5© projektraum36 GmbH & Co. KG
| 29.01.2019
What does that mean for you?
When will new
implementation guides be
published?
Unclear Timelines
Stay compliant and keep the
deadlines of all authorities
Close Deadlines
Always stay tuned to not miss
any information / requirements
Market Monitoring
New authorities have different
requirements capture them and
plan the implementation
New Requirements
Supply all authorities in
different ways
New Interfaces
Ensure that pending changes
are implemented during
operation
More Updates
Have enough developers ready
for the upcoming
implementations
More Development
Be aware that the support effort will
increase with each additional authority
More Support
Seite 6© projektraum36 GmbH & Co. KG
| 29.01.2019
6 reasons for a managed UDI Cloud Solution
Concentrate on your Core Business
The requirements affecting your UDI Processes are driven by external Authorities. A
managed Cloud Solution is close to the market and implements all requirements timely.
Less Support effort
An externally managed Cloud solution includes Support and relieves the burden on your
Support Organization.
Simplified Ressource Planning
A managed Cloud Solution scales for you with every regulatory Authority. You neither need
new hardware nor Software Development Ressources.
1
2
3
Seite 7© projektraum36 GmbH & Co. KG
| 29.01.2019
6 reasons for a managed UDI Cloud Solution
Calculable Costs
A Cloud Provider offers transparent licensing metrics for the Service Subscription. You
achieve Planning security on your whole UDI Lifecycle.
Clear Test and Change Management
A managed Solution ensures the majority of tests during Changes of the UDI Process. A
clear Change Request Handling and traceability ease to estimate the Regression Test
efforts for you.
Compliance
A managed Solution covers all requirements on the submission handling to UDI Databases
worldwide you can concentrate on the data preparation.
4
5
6
Seite 8© projektraum36 GmbH & Co. KG
| 29.01.2019
One UDI Platform for all Regulatory Authorities
The specific requirements
of the different authorities
will always be timely
implemented
New Regulatory Authorities
Your data will stay your
data. You will be
supported in transforming
the data into the
Your Data
Forced changes by the
authorities will be covered
and you will be informed
proactively
Changes
Link your existing
master-data
processes to the
Cloud-Service
Your Processes
Will be implemented
without affecting your
interface to the service
New Interfaces to Authorities
Seite 9© projektraum36 GmbH & Co. KG
| 29.01.2019
We care - our Managed Service approach
MarketMonitoring
Change Implemen-
tation
New Authority Interfaces
Validation Package
ActiveCustomer Support
ContinuousCompliance
Support
UDI Platform (as a Service)
SAP Cloud Platform
Seite 10© projektraum36 GmbH & Co. KG
| 29.01.2019
Landscape Integration
SAP PDSM
SAP ERPSAP S/4 HANA
SAP S/4 HANA Cloud
3rd Party (e.g. RIMS)
Data Maintenance
Load data from Source
Enrich data
Add authority specifics
Flexible ApprovalProcess
Data Validation
Check data consistency
Check specificauthority rules
Respect Grace Periodhandling
Data Submission
Transform data intotarget format
Submit data toauthority
Handle authorityresponses
Reporting
Trace maintenancestatus
Monitor submissionstatus
Multi-agencyReporting
UDI Platform at a glance
UDI Platform Core
Generic Data Models
Flexible Workflows
Staging Area
Sub
missio
n A
dap
ters
Flexible User Interfaces
Pre-configured Content Packages (FDA, EUDAMED)
Un
ified Su
bm
ission
Han
dlin
g
Validation Rules Audit Trail (Part 11)
Seite 11© projektraum36 GmbH & Co. KG
| 29.01.2019
SAP
Cloud
Platform
Hybrid SAP Landscape
SAP ERP
SAP S/4 HANA (Cloud)
3rd Party
SAP PDSM FDA GUDID
EUDAMED
Upcoming
AgenciesSAP ERP
RIMS
Seite 12© projektraum36 GmbH & Co. KG
| 29.01.2019
Get a first impression!
Submission Status at a glance
Data Validation
Data Maintenance
Flexible Data Models
Seite 13© projektraum36 GmbH & Co. KG
| 29.01.2019
UDI Platform - Adaptable to suit your needs
You already have maintained most of
your UDI-Data in your ERP?
Validation of your data
Simplified Release-Workflow
Submission Management
You have your device data ready but
no agency specific data?
Validation of your data
Customized Release-Workflow
Submission Management
You want to manage most of your UDI-
data in the Platform?
Data enrichment
Validation of your data
Customized Release-Workflow
Submission Management
Data enrichment
Create new maintenance flows
Seite 14© projektraum36 GmbH & Co. KG
| 29.01.2019
Integration Options
SAP ERP S/4 HANA
On-Premise
S/4 HANA
Cloud
Other
systems
REST
ODATA / CDS
ODATA
SAP SLT *
SAP SDI *
SAP PI *
SAP CPI *
* SLT = SAP Landscape Transformation | SDI = Smart Data Integration | PI = Process Integration | CPI = Cloud Process Integration | Separate licenses needed
Seite 15© projektraum36 GmbH & Co. KG
| 29.01.2019
Visit us in the SAP App Center!
Thank you for your Attention!
07.05.2018
Please contact us:
Patrick Pfau, Managing Director