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
This product is compatible with or enhances the functionality of these SAP solutions but doesn't require them.
- SAP Business Technology Platform
- SAP HANA Cloud
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.
Stay compliant with UDI
We monitor the market for new or updated requirements made by regulatory authorities, and update UDI Platform with any changes. This allows you to maintain ongoing UDI compliance.
Plans and pricing
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
validFrom1607472000000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalId43lrVSByTv6TuPirgmiJjg
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleUDI Platform Base Package - Medium/Large Enterprise
editionIde3796b55-2072-4efe-93b8-f8ab8268898e
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- 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
validFrom1577836800000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIdw52t0ed1RZKdjKbJRIUUFg
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleUSA I FDA (GUDID) Content Package
editionIdc39dadd1-e775-4592-9d8c-a6c944851416
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- 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
validFrom1577836800000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIdweplg-D1TXyflfCAQz1W-Q
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleEurope I EC (EUDAMED) Content Package
editionIdc1ea6583-e0f5-4d7c-9f95-f080433d56f9
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- EUDAMED Data Model with all necessary attributes for MDR/IVDR
- All validation and changeability rules
validFrom1629158400000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIdUMqppo_9Tm2I_qkpX9vGHQ
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleSouth Korea I MFDS (IMDIS) Content Package
editionId50caa9a6-8ffd-4e6d-88fe-a9295fdbc61d
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- IMDIS Data Model with all necessary attributes
- All validation and changeability rules
- Data submission to IMDIS database
validFrom1629158400000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIduy5Xd1HPSnutwFDnBUZEbg
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleChina I NMPA (CUDID) Content Package
editionIdbb2e5777-51cf-4a7b-adc0-50e70546446e
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- CUDID Data Model with all necessary attributes
- All validation and changeability rules
- Data submission to CUDID database
validFrom1734307200000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIdpn_-yqwuSFWbWHGcnHxs8w
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleSaudi Arabia I SFDA (SAUDI-DI) Content Package
editionIda67ffeca-ac2e-4855-9b58-719c9c7c6cf3
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- SAUDI-DI Data Model with all necessary attributes
- All validation and changeability rules
- Data submission via SFDA Excel template as soon as specifications are known
validFrom1734307200000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"labels":{"main":"Price upon request","subs":[],"ctas":[{"code":"LEAD_RFI","name":"Contact publisher","restrictions":[],"countries":[],"customProperties":{}}]}},"controls":{"hideCommitmentPeriodIdInFeatures":false}}
materialNumber8005918
internalIdKeon0H56QYmH2jIU7EhHlQ
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleTaiwan I TFDA (UDID) Content Package
editionId29ea27d0-7e7a-4189-87da-3214ec484795
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- UDID Data Model with all necessary attributes
- All validation and changeability rules
- Data submission via TFDA Excel template
validFrom1577836800000
validUntil253370723039000
priceDisplay{"freeStarterSubscriptionOrSubscription":{"global-EUR":{"labels":{"main":{"value":"2500.00","currency":"EUR"},"tooltip":true,"subs":["Per Month"],"ctas":[{"code":"LEAD_BUY","name":"Get it now","restrictions":[],"countries":[],"customProperties":{}}]}},"global-USD":{"labels":{"main":{"value":"3010.00","currency":"USD"},"tooltip":true,"subs":["Per Month"],"ctas":[{"code":"LEAD_BUY","name":"Get it now","restrictions":[],"countries":[],"customProperties":{}}]}},"global-GBP":{"labels":{"main":{"value":"2260.00","currency":"GBP"},"tooltip":true,"subs":["Per Month"],"ctas":[{"code":"LEAD_BUY","name":"Get it now","restrictions":[],"countries":[],"customProperties":{}}]}},"global-CAD":{"labels":{"main":{"value":"3900.00","currency":"CAD"},"tooltip":true,"subs":["Per Month"],"ctas":[{"code":"LEAD_BUY","name":"Get it now","restrictions":[],"countries":[],"customProperties":{}}]}}}}
materialNumber8005918
internalIda-tKbxTvQPWMNS4gplGkmw
lifeCycleStatusCode
entitlementTypes[{"commercialModels":[],"commercialModel":{"code":"subscription","name":"Subscription"},"customerType":{"code":"external","name":"external"}}]
includes[{"metric":{"code":"user","name":"User"},"amount":null,"unlimited":true}]
technicalName2001010862
titleUDI Platform Base Package - Small Enterprise
editionId6beb4a6f-14ef-40f5-8c35-2e20a651a49b
tncAvailablefalse
audiencepublic
isAddOnfalse
features[]
blocksOf{"code":null,"amount":null,"metric":null,"timeUnit":null}
commitmentPeriod{"max":null,"min":1,"unit":{"id":"months","name":"Months"}}
renewalTypes[]
prerequisites{"materialNumber":null,"materialName":null,"targetUrl":null,"andConnections":[],"orConnections":[]}
prices[{"type":"new","currency":"EUR","revenueCloudMarketId":"EUR","group":{"id":"0","validFrom":"2020-01-01T00:00:00Z"},"markets":[{"marketId":"global"}],"periodicity":{"code":"anniversary-monthly","name":"Month"},"fixedRates":[{"metricId":"fixed","metricName":"Fixed Fee","price":2500,"billedInAdvance":true}],"percentageFees":[],"setupFees":[],"allUnitVolumeRates":[],"tierRates":[],"blockRates":[]},{"type":"new","currency":"USD","revenueCloudMarketId":"USD","group":{"id":"0","validFrom":"2020-01-01T00:00:00Z"},"markets":[{"marketId":"global"}],"periodicity":{"code":"anniversary-monthly","name":"Month"},"fixedRates":[{"metricId":"fixed","metricName":"Fixed Fee","price":3010,"billedInAdvance":true}],"percentageFees":[],"setupFees":[],"allUnitVolumeRates":[],"tierRates":[],"blockRates":[]},{"type":"new","currency":"GBP","revenueCloudMarketId":"GBP","group":{"id":"0","validFrom":"2020-01-01T00:00:00Z"},"markets":[{"marketId":"global"}],"periodicity":{"code":"anniversary-monthly","name":"Month"},"fixedRates":[{"metricId":"fixed","metricName":"Fixed Fee","price":2260,"billedInAdvance":true}],"percentageFees":[],"setupFees":[],"allUnitVolumeRates":[],"tierRates":[],"blockRates":[]},{"type":"new","currency":"CAD","revenueCloudMarketId":"CAD","group":{"id":"0","validFrom":"2020-01-01T00:00:00Z"},"markets":[{"marketId":"global"}],"periodicity":{"code":"anniversary-monthly","name":"Month"},"fixedRates":[{"metricId":"fixed","metricName":"Fixed Fee","price":3900,"billedInAdvance":true}],"percentageFees":[],"setupFees":[],"allUnitVolumeRates":[],"tierRates":[],"blockRates":[]}]
salesMetric{"id":null,"name":null,"description":null,"elasticity":null}
productQuantity{"minQuantity":null,"maxQuantity":null,"quantityIncrement":null}
deploymentType
hasCustomTnCUrlfalse
hasTermsUrlfalse
hidePricefalse
- 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
productMarkets["AX","CN","UA","BY","IQ","ZW","ZM","ZA","YT","YE","WS","WF","VU","VN","VI","VG","VE","VC","VA","UZ","UY","UG","TZ","TW","TV","TT","TR","TO","TN","TM","TL","TK","TJ","TH","TG","TF","TD","TC","SZ","SV","ST","SR","SO","SN","SM","SL","SK","SJ","SI","SH","SG","SE","SC","SB","SA","RW","RS","RO","RE","QA","PY","PW","PS","PR","PN","PM","PL","PK","PH","PG","PF","PE","PA","OM","NZ","NU","NR","NP","NO","NL","NI","NG","NF","NE","NC","NA","MZ","MY","MX","MW","MV","MU","MT","MS","MR","MQ","MP","MO","MN","MM","ML","MK","MH","MG","ME","MD","MC","MA","LY","LV","LU","LT","LS","LR","LK","LI","LB","LA","KZ","KY","KW","KR","KN","KM","KI","KH","KG","KE","JP","JO","JM","JE","IS","IO","IL","IE","ID","HU","HT","HR","HN","HM","HK","GY","GW","GU","GT","GS","GR","GQ","GP","GN","GM","GL","GI","GH","GG","GF","GE","GD","GB","GA","FO","FM","FK","FJ","ET","ES","ER","EH","EG","EE","EC","DZ","DO","DM","DK","DJ","CZ","CY","CX","CV","CR","CO","CM","CL","CK","CI","CG","CF","CD","CC","CA","BZ","BW","BV","BT","BS","BO","BN","BM","BJ","BI","BH","BF","BE","BD","BB","BA","AZ","AW","AS","AR","AQ","AO","AM","AL","AI","AG","AF","AE","AD","US","PT","IT","IN","FR","FI","DE","CH","BR","BG","AU","AT","IM","BL"]
Customer reviews
65c41abe-f121-4f7e-b29b-bac710279e6f
Technical Information
Technical details
| Solution type | Extensions and Add-ons |
| Category | Data and Analytics |
| Industry | Life Sciences |
| Works with |
|
Deployment and operations
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.
| Deployment |
|
| Globalization |
|
| Operations |
|
Security and compliance
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 |
|
| Compliance |
|
| 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. |
terms-and-conditions-url
https://www.p36.io/contact/?lang=en
technical-name
2001010862
is-partner
true
support-email
mailto:contact@p36.io
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.
More solutions provided by {{publisher}} p36 GmbH
products
2001015813
service1label
Ask publisher
service1url
contact-leadform
service1description
Contact the publisher for further details
service1icon
contact-publisher
service1edition
43lrVSByTv6TuPirgmiJjg:LEAD_RFI
service2label
Contact support
service2url
https://store.sap.com/dcp/en/supportform
service2description
Submit a support ticket for assistance with any questions or issues
service2icon
contact-support