atrify GxP Compliance
Manage your UDI data and submissions with GxP compliance
atrify and USDM provide an industry-leading UDI solution. Our solution includes definitive guidance and understanding of the UDI regulations, guidance on the label, DM, and IFU requirements, revision to QMS SOPs and systems, support for data collection and management, and the platform for data management and data submissions to the UDI databases in a compliant manner.
Medical device manufacturers benefit from a clear path from your current state to your desired future state. A future state in which your company has established processes, SOPs, labels, systems, and resources for data collection, approval, storage, submissions, device and database updates, and a set plan for new agencies.
USDM and atrify can support your business processes by:
- Providing continual compliance and updates on global UDI regulations and the key dates, data requirements, and label requirements
- Assessing your current state and developing a UDI program to meet your company’s requirements for your specific products
- Revising your QMS processes and SOPs required by the UDI regulations
- Collecting the required UDI data, planning, and supporting the implementation of the UDI data storage
- Implementing the atrify UDI platform and providing best practice, training, and data loading support
- Providing ongoing UDI guidance for device updates, changes in regulations, and new agency regulations
- Providing the initial validation of the atrify UDI platform and continuous compliance through atrify releases
- Provide certified quality auditors
- Utilize a methodology and toolkit successfully audited by regulatory agencies
- Significantly reduce implementation and validation time
- Decrease the cost of managing cloud compliance
- Accelerate innovation with a platform of compliant-ready solutions
- Optimize business operations with Workflow as a Service
atrify’s UDI Platform
Medical device registration. Compliant, safe, and easy.
The atrify UDI platform enables medical device manufacturers to master their UDI challenge and ensures the compliant, fast and simple transfer of UDI device data to UDI databases.
Depending on the number of UDIs, data can be transferred depending on your needs and preferences.
- Automatically machine-to-machine
- Excel Bulk Upload
- Manual data entry in a user-friendly web interface
Examples of vital added-value functionalities:
- Track & Trace: Track your registration status with EUDAMED. See all linked UDI-DIs of a Basic-UDI (EUDAMED).
- Notifications: Personalized notification service to keep up to date with the registration status of your devices.
- Device Hit List: Search, find, and filter your devices quickly. See the most important attributes and the status at a glance.
- Flexible Connections/Uploads: Manually upload your medical devices via Excel or connect via M2M.
- Pre-built integrations with major PIM and PLM solutions.
- Improved validation processes with USDM Cloud Assurance.
- Available out-of-the-box
Decades of Experience and Trust
atrify plays an active role in shaping decisions on the subject of UDI thanks to many years of involvement in committees of authorities and associations. They strive to be a trusted advisor in providing customers with the latest information and market assessments. Some of atrify’s credentials include:
- Co-chair of the EUDAMED IT Expert Group (MedTech Europe)
- Close cooperation with the European Commission and other Regulators – part of the MDCG working groups (European Commission)
- Member of GS1 Global Healthcare Leadership Team
- ISO 27001 certified
- Host of Healthcare user groups to share information and help direct atrify’s priorities related to GDSN & UDI development
- Provide in-depth support and services for Early adopters of new UDI databases
- 100% GS1 Germany subsidiary
Learn how to harness the latest technology trends with data collaboration platforms like atrify in our latest
2023 Technology Trends in Life Sciences White Paper.