EUDAMED Onboarding Services
Innovit
Innovit provides GDSN and UDI compliance solutions, specializing in EUDAMED and AusUDID data management for medical device manufacturers. Streamline regulatory compliance and data exchange.
Innovit offers specialized solutions for EUDAMED and AusUDID compliance, crucial for medical device manufacturers navigating complex global regulatory landscapes. Their GDSN Connector and EUDAMED.cloud system simplify the management, validation, and exchange of trusted product data, ensuring adherence to mandatory deadlines and requirements. With a focus on improving data quality and enabling regulatory compliance, Innovit's platforms help organizations manage UDI data, validate BUDI information, and prepare for submissions to regulatory bodies like the EU Commission and Australia's TGA. They provide tools for training, testing, and seamless data export, supporting both large-scale submissions and individual device registrations. Innovit's expertise extends to multi-domain Master Data Management (MDM) and workflow automation, assisting healthcare providers, medical device suppliers, and GPOs & Distributors in achieving and maintaining compliance. Their solutions are designed to reduce procurement spend, enhance supply chain analytics, and ultimately improve patient safety by ensuring accurate and accessible product data.
About
**Who they are**
EUDAMED Onboarding Services is a specialized provider focused on GDSN and UDI compliance solutions, with a particular emphasis on EUDAMED and AusUDID data management for medical device manufacturers. They aim to simplify regulatory compliance and data exchange processes.
**Expertise & scope**
* EUDAMED data management
* AusUDID data management
* GDSN compliance solutions
* UDI compliance solutions
* Support for medical device manufacturers
**Reputation / proof points**
* Coverage includes the EU and US markets.
EUDAMED Onboarding Services is a specialized provider focused on GDSN and UDI compliance solutions, with a particular emphasis on EUDAMED and AusUDID data management for medical device manufacturers. They aim to simplify regulatory compliance and data exchange processes.
**Expertise & scope**
* EUDAMED data management
* AusUDID data management
* GDSN compliance solutions
* UDI compliance solutions
* Support for medical device manufacturers
**Reputation / proof points**
* Coverage includes the EU and US markets.
Additional information
For medical device manufacturers navigating the complexities of EUDAMED and AusUDID, EUDAMED Onboarding Services offers streamlined solutions. Their focus on data management helps ensure that manufacturers can efficiently meet regulatory requirements for device registration and compliance. Buyers can expect a dedicated approach to managing the specific data exchange needs associated with these regulatory frameworks.
Key Highlights
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Specializes in EUDAMED and AusUDID data management.
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“specializing in EUDAMED and AusUDID data management”
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Provides GDSN and UDI compliance solutions.
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“Innovit provides GDSN and UDI compliance solutions”
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Supports medical device manufacturers.
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“for medical device manufacturers”
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Services cover the EU and US markets.
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“Coverage: EU, US”
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Available in English, French, and German.
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“Languages: English, French, German”
Certifications & Trust Signals
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Serving clients in GB
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“Regulatory compliance expertise”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EUDAMED and AusUDID compliance
- Companies needing to streamline GDSN and UDI data management
How engagement typically works
- Focused on data management and regulatory compliance
- Specialized support for EUDAMED and AusUDID
Typical deliverables
- EUDAMED data registration support
- AusUDID data management
- GDSN compliance solutions
- UDI compliance solutions
Good to know
- Best when requiring specialized EUDAMED and AusUDID expertise
HQ:
Austin, US
Languages:
English, French, German
Timezones:
GMT, CET
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU, US
Countries:
GB
Industries:
Medical Devices
Onboarding time:
7–14 days
Pricing model:
Custom pricing
Modules Supported:
UDI/Devices
Submission Approach:
Bulk Submissions
Portfolio Fit:
100+
Onboarding Speed:
2-6 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping
Additional eudamed_onboarding_support Details
Modules Supported
EUDAMED
Submission Approach
Portal operations, managed services
