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) is designed to streamline the process of accessing and integrating information from EU and US medical device databases. Their platform aids in achieving compliance with UDI regulations by providing a centralized search capability. This service is particularly useful for organizations that need to manage and report on medical device data across different regulatory jurisdictions. The focus is on enabling efficient M2M integration, suggesting capabilities for automated data exchange and system interoperability.

Key Highlights

  • 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”
  • Provides EudaMed Bronze (SaaS) for EUDAMED bulk uploads. Source
    “EudaMed Bronze (SaaS) – EUDAMED Bulk Uploads”
  • 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”
  • 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 needing to comply with UDI regulations.
  • Organizations requiring M2M integration with medical device databases.
  • Businesses searching EU and US medical device information.
How engagement typically works
  • Platform-based service for data access and integration.
Typical deliverables
  • Access to a comprehensive search engine for medical device databases.
  • Tools and capabilities to support M2M integration.
  • Assistance with UDI compliance.
Good to know
  • Best when specific M2M integration capabilities or database search functionalities are required.
HQ: US
Languages: English
Status: listed

Services & Capabilities

EUDAMED M2M Integration

Supported Modules: UDI/Devices
Provides Access Point: Yes
API Documentation Available: Yes

Additional eudamed_m2m Details

Supported Modules
UDI/Devices
API Documentation
Information not publicly available.
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