tracekey (mytracekey UDI Manager)
tracekey solutions GmbH
tracekey provides RegTech solutions for the Life Science industry, specializing in UDI management for MedTech and Pharma. They offer intelligent, scalable software to ensure compliance with global regulatory requirements.
tracekey solutions GmbH is a German-based company offering RegTech solutions tailored for the Life Science industry, with a strong focus on UDI management for MedTech and Pharma sectors. Their flagship product, mytracekey UDI Manager, helps companies navigate complex global regulatory requirements, ensuring compliance with standards like EUDAMED. They emphasize creating intuitive, efficient, and cost-effective software that simplifies compliance without hindering innovation. tracekey's solutions are designed to be scalable and secure, supporting companies in meeting stringent regulatory demands and enhancing patient safety through improved traceability of medical devices. With a commitment to transparency and high standards, tracekey assists businesses in achieving worldwide serialization compliance and managing UDI data effectively. Their expertise extends to understanding various international regulatory landscapes, including those in the EU and Australia, positioning them as a key partner for life science organizations.
About
**Who they are**
tracekey (mytracekey UDI Manager) is a RegTech solutions provider for the Life Science industry, focusing on UDI management for MedTech and Pharma.
**Expertise & scope**
* Provides intelligent, scalable software to ensure compliance with global regulatory requirements.
* Specializes in UDI management solutions for the MedTech sector, including the mytracekey UDI Manager.
* Offers solutions for the pharmaceutical industry, such as mytracekey PHARMA, mytracekey ALERTS, mytracekey TKSM, and mytracekey HospitalDirect.
* Addresses EUDAMED Actor Registration Module requirements, explaining roles like European Commission, competent authorities, notified bodies, manufacturers, authorized representatives, and importers.
* Details Australian UDI requirements, including TGA guidelines, timelines, and labeling obligations, with a focus on the AusUDID system.
* Explains the role of a Sponsor in Australia, comparable to an Authorized Representative in the EU, responsible for UDI compliance.
**Reputation / proof points**
* Offers solutions for both MedTech and Pharma sectors.
* Addresses global regulatory requirements.
tracekey (mytracekey UDI Manager) is a RegTech solutions provider for the Life Science industry, focusing on UDI management for MedTech and Pharma.
**Expertise & scope**
* Provides intelligent, scalable software to ensure compliance with global regulatory requirements.
* Specializes in UDI management solutions for the MedTech sector, including the mytracekey UDI Manager.
* Offers solutions for the pharmaceutical industry, such as mytracekey PHARMA, mytracekey ALERTS, mytracekey TKSM, and mytracekey HospitalDirect.
* Addresses EUDAMED Actor Registration Module requirements, explaining roles like European Commission, competent authorities, notified bodies, manufacturers, authorized representatives, and importers.
* Details Australian UDI requirements, including TGA guidelines, timelines, and labeling obligations, with a focus on the AusUDID system.
* Explains the role of a Sponsor in Australia, comparable to an Authorized Representative in the EU, responsible for UDI compliance.
**Reputation / proof points**
* Offers solutions for both MedTech and Pharma sectors.
* Addresses global regulatory requirements.
Additional information
tracekey's solutions are designed to integrate with regulatory databases. For instance, their UDI requirements for Australia align with the EU's EUDAMED and Switzerland's Swissdamed, with product entries in AusUDID linking to the Australian Register of Therapeutic Goods (ARTG). They provide access to both test and production environments for systems like AusUDID, allowing manufacturers and sponsors to familiarize themselves with the platform before live data entry. The company emphasizes scalable software to meet evolving global regulatory demands.
Key Highlights
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Provides RegTech solutions specializing in UDI management for MedTech and Pharma.
Source
“tracekey provides RegTech solutions for the Life Science industry, specializing in UDI management for MedTech and Pharma.”
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Explains EUDAMED Actor Roles, including supervising and economic actors.
Source
“The EUDAMED Actor Roles are part of the Actor Registration Module. It is the first of the six modules to be made available to the public.”
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Details Australian UDI requirements and the AusUDID system.
Source
“In Australien führt die Therapeutic Goods Administration (TGA) UDI im Rahmen ihrer Reformen für Medizinprodukte ein, um sich an internationale Standards anzupassen und die Patientensicherheit zu erhöhen.”
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Offers specific software solutions like mytracekey UDI Manager and mytracekey PHARMA.
Source
“mytracekey MEDTECH mytracekey UDI Manager”
Certifications & Trust Signals
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Offers intelligent, scalable software to ensure compliance with global regulatory requirements.
Source
“They offer intelligent, scalable software to ensure compliance with global regulatory requirements.”
Buyer Snapshot
Best for
- MedTech companies needing UDI management solutions.
- Pharmaceutical companies seeking regulatory compliance software.
- Organizations navigating EUDAMED actor registration.
How engagement typically works
- Software-as-a-Service (SaaS) model.
- Focus on scalable and intelligent solutions.
Typical deliverables
- UDI Management Software (mytracekey UDI Manager).
- Pharmaceutical Regulatory Software (mytracekey PHARMA suite).
- Compliance guidance for EUDAMED and Australian TGA regulations.
Good to know
- Best when organizations require specialized RegTech solutions for MedTech and Pharma.
- Suitable for companies needing to comply with global UDI and EUDAMED regulations.
HQ:
Bochum, Germany
Languages:
German
Timezones:
UTC+1
Status:
listed
Services & Capabilities
EUDAMED M2M Integration
Supported Modules:
Actor, UDI/Devices
Additional eudamed_m2m Details
Supported Modules
Actor Registration Module
