tracekey UDI Manager
tracekey solutions GmbH
tracekey solutions GmbH offers the mytracekey UDI Manager, a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework. They focus on simplifying compliance with EU regulations.
tracekey solutions GmbH provides the mytracekey UDI Manager, a comprehensive software solution tailored for medical device manufacturers navigating the complexities of UDI (Unique Device Identification) registration within the EUDAMED database. Their offering emphasizes simplifying the process of data collection, processing, and pre-validation to ensure compliance with stringent EU regulations. The mytracekey UDI Manager assists manufacturers in pre-validating their master data before submission to EUDAMED. This proactive approach helps identify and correct potential errors, such as incorrect formatting, misplaced digits, or missing information, thereby reducing the risk of upload failures and the time-consuming detective work often associated with EUDAMED error messages. The tool supports various upload methods, including manual entry, XML bulk upload, and M2M connections, adapting to different project needs. With a focus on making compliance intuitive and efficient, tracekey solutions GmbH aims to empower companies in the healthcare sector to meet global regulatory requirements without hindering innovation. Their solutions are designed to be scalable and cost-effective, ensuring that regulatory adherence is manageable and precise for each client's specific needs. They are based in Germany, emphasizing transparency and high standards in their services.
About
**Who they are**
tracekey UDI Manager provides specialized software solutions for medical device manufacturers, focusing on streamlining compliance with EU regulations like EUDAMED.
**Expertise & scope**
* Specializes in EUDAMED UDI registration and master data pre-validation.
* Offers the mytracekey UDI Manager software solution.
* Assists with navigating EUDAMED Actor Roles, including understanding the differences between supervising and economic actors.
* Supports UDI registration through manual entry, XML bulk upload, and M2M connections.
* Aims to improve data quality and compliance with EUDAMED's business rules.
* Addresses common errors in UDI registration and provides methods for prevention and correction.
**Reputation / proof points**
* Headquarters in the EU.
* Coverage across the EU.
tracekey UDI Manager provides specialized software solutions for medical device manufacturers, focusing on streamlining compliance with EU regulations like EUDAMED.
**Expertise & scope**
* Specializes in EUDAMED UDI registration and master data pre-validation.
* Offers the mytracekey UDI Manager software solution.
* Assists with navigating EUDAMED Actor Roles, including understanding the differences between supervising and economic actors.
* Supports UDI registration through manual entry, XML bulk upload, and M2M connections.
* Aims to improve data quality and compliance with EUDAMED's business rules.
* Addresses common errors in UDI registration and provides methods for prevention and correction.
**Reputation / proof points**
* Headquarters in the EU.
* Coverage across the EU.
Additional information
tracekey's mytracekey UDI Manager is designed to simplify the complex process of UDI registration within the EUDAMED framework. The solution emphasizes pre-validation of master data to ensure accuracy and compliance before submission. Manufacturers can choose from various data upload methods, including manual entry, XML bulk uploads, and direct machine-to-machine (M2M) connections, each with its own advantages and potential pitfalls. The company highlights the importance of accurate data collection and processing to avoid common errors that can arise during the registration process, offering insights into how to prevent and resolve these issues.
Key Highlights
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Offers the mytracekey UDI Manager, a specialized software for EUDAMED UDI registration and master data pre-validation.
Source
“tracekey solutions GmbH offers the mytracekey UDI Manager, a specialized software solution designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework.”
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Provides support for various EUDAMED Actor Roles, distinguishing between supervising and economic actors.
Source
“The European Union defines an actor as: A natural or legal person (organization) with a specific role that must be registered in EUDAMED.”
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Facilitates UDI registration through multiple upload methods: manual entry, XML bulk upload, and M2M connections.
Source
“There are three possibilities to upload data into EUDAMED: The manual entry, the XML bulk upload, and the M2M connection.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers needing to comply with EUDAMED UDI requirements.
- Companies seeking to streamline their UDI registration and master data management.
How engagement typically works
- Software solution provider.
- Focus on simplifying regulatory compliance.
Typical deliverables
- mytracekey UDI Manager software.
- Guidance on EUDAMED Actor Roles.
- Support for UDI data pre-validation.
- Assistance with data upload methods (XML, M2M).
Good to know
- Best when integrated into existing data management workflows.
- Requires understanding of EUDAMED's business rules for optimal use.
HQ:
Bochum, DE
Languages:
English, German
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, ES, AT, NL, DK, DE
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–30 days
Pricing model:
Usage-based
Starting from:
EUR 800
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eudamed_onboarding_support
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Requires manufacturers to input product information into the database accurately and in accordance with EUDAMED's business rules. Offers solutions for pre-validating data before submission.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor Registration, UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
false
Supports Clinical Investigations
false
