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 navigating EUDAMED compliance. They focus on streamlining the complex processes associated with UDI registration and master data pre-validation within the European Union regulatory framework.
**Expertise & scope**
* Offers the mytracekey UDI Manager, a dedicated tool for EUDAMED registration and UDI data management.
* Addresses the challenges of consolidating UDI data from disparate sources like Excel files, ERP systems, and physical records.
* Provides solutions for manufacturers of all sizes, from SMEs to international companies, to meet MDR and IVDR requirements.
* Facilitates the preparation and submission of product master data required by EUDAMED.
* Aims to simplify compliance with EU regulations, particularly concerning the EUDAMED database.
**Reputation / proof points**
* Focuses on providing a long-term solution for the ongoing EUDAMED project, acknowledging its complexity and evolving nature.
tracekey UDI Manager provides specialized software solutions for medical device manufacturers navigating EUDAMED compliance. They focus on streamlining the complex processes associated with UDI registration and master data pre-validation within the European Union regulatory framework.
**Expertise & scope**
* Offers the mytracekey UDI Manager, a dedicated tool for EUDAMED registration and UDI data management.
* Addresses the challenges of consolidating UDI data from disparate sources like Excel files, ERP systems, and physical records.
* Provides solutions for manufacturers of all sizes, from SMEs to international companies, to meet MDR and IVDR requirements.
* Facilitates the preparation and submission of product master data required by EUDAMED.
* Aims to simplify compliance with EU regulations, particularly concerning the EUDAMED database.
**Reputation / proof points**
* Focuses on providing a long-term solution for the ongoing EUDAMED project, acknowledging its complexity and evolving nature.
Additional information
The mytracekey UDI Manager is positioned as a long-term solution for the EUDAMED project, recognizing that EUDAMED is not a one-time task but an ongoing process. The solution addresses the time-intensive nature of collecting product master data from various sources and the complexity of understanding EUDAMED's specific data requirements. It helps filter and prepare data, ensuring that mandatory and optional attributes are correctly identified and populated for submission.
Key Highlights
-
The mytracekey UDI Manager is designed to streamline UDI registration and master data pre-validation for medical device manufacturers within the EUDAMED framework.
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.”
-
The solution addresses the challenges of consolidating UDI data from various sources, including Excel files, ERP systems, and physical records.
Source
“The data often comes from various Excel files, ERP systems or even physical folders, which makes consolidation even more difficult.”
-
EUDAMED is viewed as a long-term project, and the mytracekey UDI Manager is presented as an ideal long-term solution to manage this ongoing process.
Source
“For the upcoming effort with EUDAMED, we have developed the ideal long-term solution with the mytracekey UDI Manager.”
-
The provider offers specific use cases and examples for manufacturers to understand how to manage their UDI processes and EUDAMED submissions.
Source
“The following case studies, developed based on real customer experiences, provide insights into typical situations and decision-making processes.”
Certifications & Trust Signals
-
Operates within the EU regulatory framework for medical devices.
Source
“Addresses EUDAMED Actor Roles, part of the Actor Registration Module.”
Buyer Snapshot
Best for
- Medical device manufacturers needing to comply with EUDAMED regulations.
- Companies seeking to streamline UDI registration and data management.
How engagement typically works
- Software solution provider.
- Focus on simplifying complex regulatory processes.
Typical deliverables
- mytracekey UDI Manager software.
- Assistance with UDI data consolidation and pre-validation.
- Support for EUDAMED data submission.
Good to know
- Best when dealing with significant volumes of UDI data.
- Best when data is currently fragmented across multiple systems.
HQ:
Bochum, DE
Languages:
English, German
Timezones:
Europe/Brussels
Claim 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
The process involves collecting product master data from various sources, filtering and preparing the data according to EUDAMED requirements, and then submitting it.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
false
Supports Clinical Investigations
false
⚡ Instant booking available
Book EU EUDAMED Actor & UDI Setup Support
Compare tracekey UDI Manager and other vetted providers — instant pricing, no RFQ needed.
