UDI, FDA GUDID, HL7 SPL Submission, UDI for Medical Devices

Freyr Roadmap to UDI Compliance

Keeping the timelines in mind, Freyr offers a well-defined roadmap to fast-track UDI compliance comprising of a 3-step process. This process signifies Freyr’s dedication to assist and support medical device companies to attain industry compliance.

Global Unique Device Identification Data base (GUDID)

The GUDID serves as the repository of key device identification information which can be accessible by public. The DI serves as the primary key to obtain device information in database.

Freyr Leverage

• 2 – 4 Week UDI Readiness Assessment

• Complete GAP Analysis to meet project’s objectives and timelines

• Developing an effective roadmap for UDI implementation

• Adept Data Management (collection, collation, validation and conversion)

• A 21 CFR Part 11 compliant ready-to-deploy UDI Software solution for effective Data Management and fast-track UDI compliance

• Preparation and UDI Submission Status Reports

• A robust, agile and scalable UDI system to manage complex submissions

• Support for current and future submissions with 360° lifecycle maintenance

• Centralized repository for audit requests and regulatory submissions

• Creating validated HL7 SPL Submission Packages, 21 CFR Part 11 compliant