Implement global UDI
requirements
quickly and easily

Complying with UDI regulations from various regulatory bodies is a complex task. With the UDI Platform, you keep control of your UDI data at all times.

UDI Platform

UDI Platform

With our cloud-based UDI Platform, you can manage the data of your medical devices centrally in one place and exchange it directly with the regulatory authorities – flexible, simple, and compliant.

Centralized data management and configuration

The UDI Platform is tailored to your needs and internal processes. It allows you to easily prepare data, quickly validate, and easily transfer your UDI data to the authorities. With the UDI Platform you always keep track of your data.

Active market monitoring

Stay on top of markets and UDI regulations. We make ensuring your UDI compliance easy. We constantly analyze the requirements of relevant markets and promptly implement changes. This ensures that your data is always up-to-date.

Seamless integration

The UDI Platform can be seamlessly integrated into your existing system landscape, allowing you to incorporate existing data. A close integration with the authorities’ systems enables you to directly exchange data both, from and into the UDI Platform and your internal systems.

Our success? The success of our customers

We were looking for a state-of-the-art cloud-based solution that is modularly expandable, technically scalable and which can meet global UDI requirements. It was important to us that the platform would be easy to explain and could be used intuitively by different user groups. The p36 solution was clearly ahead in all of these areas.

Dr. Antje Giffing, Head of Regulatory Affairs, Raumedic AG
Sebastian Deeg, Head of Information Technology, Raumedic AG

The core of the UDI Platform –
our Content Packages

✓ GUDID Data Model with all required attributes
✓ All validation and changeability rules
Grace period handling
Unlocking functionality for critical corrections
✓ Data submission to GUDID database

✓ EUDAMED Data Model with all necessary attributes for MDR/IVDR
All validation and changeability rules

IMDIS Data Model with all necessary attributes
All validation and changeability rules
Data submission to IMDIS database

✓ CUDID Data Model with all necessary attributes
All validation and changeability rules
Data submission to CUDID database

SAUDI-DI Data Model with all necessary attributes
All validation and changeability rules
Data submission via SFDA Excel template

UDID Data Model with all necessary attributes
All validation and changeability rules
Data submission via TFDA Excel template

More information to follow as soon as Content Package is available.

More information to follow as soon as Content Package is available.

Compliance dates

All benefits at a glance

Market monitoring

Active monitoring and rapid implementation of new UDI requirements

Reuse of data

Reuse existing data for new markets

Process automation

Configuration and automation of processes for faster UDI compliance

Flexible extension

Global and scalable concept for upcoming UDI regulations

Expert team

Experienced team of experts for global UDI compliance

Get to know the UDI Platform

Demo Video Industry Cloud : UDI Platform by p36 (English)

Demo Video Master the Global UDI Compliance Challenge (English)

We offer more than software.We are your partner to ensure permanent UDI.

1. Concept

In our workshops, you get to know us and our solution. Your requirements are captured based on our established standard procedure.

2. Implementation

Based on your specifications, we set up the UDI Platform for your company. We also take care of migrating your existing data.

3. Test

In an extensive testing-phase we check the UDI Platform with regard to your requirements.

4. Go-Live

After your go-live decision, we activate the UDI Platform and monitor its smooth operation.

5. Support

We are always at your side during and after the implementation of the UDI Platform. If there are new UDI requirements that affect you, we ensure timely implementation. In this way, you always remain UDI compliant.

Do you have any questions? Contact me personally:

Alexander Parr

Business Unit Lead UDI Platform

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