Eudamed.com (EirMed)
EirMed
Eudamed.com (EirMed) provides a comprehensive search engine for EU and US medical device databases, facilitating M2M integration and UDI compliance.
Eudamed.com, also known as EirMed, offers a specialized search engine designed to navigate and extract information from both EU and US medical device databases. This platform is crucial for businesses seeking to understand regulatory landscapes and device compliance. It specifically supports Machine-to-Machine (M2M) integration, allowing for seamless data exchange and automated processes. Furthermore, Eudamed.com aids in managing Unique Device Identification (UDI) requirements, ensuring that manufacturers and distributors meet global standards. The service is geared towards streamlining access to critical device information for various stakeholders within the medical device industry.
About
Eudamed.com (EirMed) operates a comprehensive search engine for EU and US medical device databases. This service is designed to facilitate Machine-to-Machine (M2M) integration and support Uniform Device Identification (UDI) compliance for medical device manufacturers and related entities. The platform aims to streamline the process of accessing and managing regulatory information across key international markets, assisting businesses in navigating complex compliance landscapes.
Additional information
Eudamed.com (EirMed) assists businesses in navigating the complexities of medical device regulations, particularly concerning M2M integration and Unique Device Identification (UDI) compliance. Their service centers around a search engine that aggregates information from EU and US medical device databases, aiming to streamline compliance efforts for manufacturers and stakeholders. This can be particularly useful for companies needing to ensure their devices meet the data submission and identification requirements in these key markets.
Key Highlights
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Offers EudaMed+ software for automated EUDAMED submissions, UDI DI cloning, and version control.
Source
“EudaMed+ provides fully automated EUDAMED submissions of your validated device data, this includes time-saving UDI DI cloning functionality”
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Provides EudaMed Bronze (SaaS) for EUDAMED bulk uploads.
Source
“EudaMed Bronze (SaaS) – EUDAMED Bulk Uploads”
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Offers EUDAMED Check service for SRN activity monitoring and proof of UDI DI existence.
Source
“Our EUDAMED Check service will provide you with PDFs and JSON data of all your SRN EUDAMED submissions”
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Provides training on MDR & IVDR EUDAMED requirements for various professional teams.
Source
“Exclusive EUDAMED training for your IT team, management, RA and QA professionals on the MDR & IVDR EUDAMED requirements.”
Buyer Snapshot
Best for
- Companies seeking to integrate medical device data across systems.
- Organizations needing to ensure UDI compliance.
- Businesses requiring access to EU and US medical device regulatory information.
How engagement typically works
- Information access and data integration support.
Typical deliverables
- Access to a comprehensive search engine for medical device databases.
- Facilitation of M2M integration for compliance purposes.
Good to know
- Best when focused on EU and US medical device markets.
- Requires integration planning for M2M capabilities.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
EUDAMED M2M Integration
Supported Modules:
UDI/Devices, Vigilance
Provides Access Point:
Yes
API Documentation Available:
No
Domibus Based:
No
Provides Sandbox:
No
Monitoring And Logs:
Yes
SLA For Errors:
Custom
Additional eudamed_m2m Details
Supported Modules
UDI/Devices
API Documentation
Information not publicly available.
