About UDI Experts
The conception of UDI Experts was initiated by Hussam Mostafa in 2018. He noticed several MedTech organizations not fully understanding what Unique Device Identification (UDI) is and the main purpose behind UDI for a device.
In addition, the UDI data initially being collected and registered by these organizations was not accurate and incomplete, which resulted in negative consequences such as device recalls.
For these reasons, Hussam established UDI Experts, a global UDI solutions provider for both medical and in-vitro diagnostic device organizations.
UDI Experts Premier Solutions
- Data Registration: End-to-end data collection, verification, validation, and module submission.
- Technical Documentation: Optimization of UDI procedures, work instructions, and SOPs.
- Staff Augmentation: Providing flexible, on-demand expertise to support internal teams.
- Label Optimization: Ensuring compliant UDI label development (e.g., FDA US 21 CFR 11) and printing services. UDI Experts also provides labeling printer support (Installation Qualification/Operation Qualification/Performance Qualification) for printers housed by manufacturers.
Additional Medical Device Solutions
Provided through UDI Experts' network. See the Our Services tab for more details.
- Executing device design and risk management activities (including combination products)
- Obtaining device market clearance (EU, US, and other markets)
- QMS and internal auditing
- European Union (EU) Authorized Representative (SRN BE-AR-000011902) and EU Importer (BE-AR-000019599) support
- PDLM and PLM system provider