p36.io
p36.io offers innovative cloud software solutions, specializing in the UDI Platform for Life Sciences companies. They streamline product data management and regulatory compliance for global market access.
p36.io is your partner for innovative cloud software solutions, dedicated to accelerating digital transformation within the Life Sciences industry. They help companies optimize processes, reduce costs, and simplify collaboration by leveraging modern cloud technologies. Their flagship product, the UDI Platform, is a cloud-based solution designed to manage medical device data centrally and facilitate direct exchange with regulatory authorities. This platform ensures flexibility, simplicity, and compliance with global UDI regulations. It is individually tailored to meet specific business needs and internal processes, enabling easy data preparation, rapid validation, and straightforward submission to authorities. p36.io also focuses on keeping clients informed about evolving market requirements and UDI regulations, ensuring data remains up-to-date. The UDI Platform integrates seamlessly with existing IT landscapes and regulatory systems, allowing for the transfer of existing data and direct data exchange. Beyond the UDI Platform, p36.io offers expertise in Cloud Consulting and Cloud Service Qualification, helping businesses navigate GxP-compliant cloud environments and manage the complexities of cloud transformation.
Key Highlights
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Offers a specialized UDI Platform for Life Sciences companies.
Source
“p36.io offers innovative cloud software solutions, specializing in the UDI Platform for Life Sciences companies.”
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Facilitates direct data exchange with regulatory authorities.
Source
“Mit unserer Cloud-basierten UDI Platform können Sie die Daten Ihrer Medizinprodukte zentral an einem Ort verwalten und direkt mit den Regulierungsbehörden austauschen”
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Provides customizable solutions tailored to specific needs and processes.
Source
“Die UDI Platform wird individuell auf Ihre Bedürfnisse und internen Prozesse zugeschnitten.”
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Supports data preparation, validation, and transfer to authorities.
Source
“Sie ermöglicht Ihnen eine einfache Datenaufbereitung, schnelle Validierung und unkomplizierte Übertragung Ihrer UDI-Daten zu den Behörden.”
Buyer Snapshot
Best for
- Life Sciences companies needing to manage UDI data.
- Organizations seeking streamlined product data management for regulatory compliance.
How engagement typically works
- Customizable platform implementation.
- Cloud-based software solutions.
Typical deliverables
- UDI Platform software.
- UDI data management and submission support.
- Cloud consulting services.
Good to know
- Best when a centralized, cloud-based approach to UDI data management is desired.
HQ:
Germany
Languages:
German, English
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
UDI/Devices
Submission Approach:
M2M Integration
Portfolio Fit:
1-5
Onboarding Speed:
2-6 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping
Additional eudamed_onboarding_support Details
Modules Supported
UDI/Devices
Submission Approach
Portal operations
Validation Playbook
Data preparation and validation are supported as part of the platform's functionality.
