Precise, Efficient, Swifter
Freyr UDI Compliance
U.S. Food and Drug Administration (US FDA) declared the latest requirement to identify medical devices that involve its safe and efficient use during the use of UDI on September 24, 2013.
Freyr UDI Regulation Overview
Medical Device manufacturer corporations have to generate and keep the Unique Device Identifier (UDI), which is precise to a device model, and a production identifier that comprises of current production information such as the lot or batch number, the serial number and/or expiration date for specific device.
UDI will be a unique numeric or alphanumeric code comprising of two parts, DI – identifies the labeller and the specific version or model of the device and PI – varying portion of UDI, a blend of lot/batch number, serial number, etc.
Freyr UDI Implementation Timelines
The implementation timelines for UDI are based on the degree of probability the medical device has, starting from Class III, Sept, 2014 to Class I in future. Though many low-risk medical devices will be freed from some or all of the constraints of the Final Rule.
Freyr offers a well-defined roadmap to fast-track UDI compliance comprising of a 3-step process focussing on timelines. This method indicates Freyr’s dedication to help and sustain medical device companies to achieve industry compliance.
Handling huge volumes of unstructured information from disparate and non-authenticated sources effectively is one of the greatest challenges for manufacturers in acquiring their UDI compliance obligations. Additionally, the lack of version control measures, clumsy manual submission and insufficient data management procedure makes the tasks difficult to manage.
With the timelines becoming shorter every day, enterprises are eyeing out for a right partner with an efficient solution to productively navigate through the UDI landscape. Freyr IDENTITY offers the plan, process and training approach to extend an end-to-end UDI compliance solution.
Freyr IDENTITY guarantees reliable Regulatory compliance with GxP practice 21 CFR Part 11, comprising of additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to allow precise, efficient and quicker UDI compliance.
Freyr UDI Expertise
- Data Management & Source Configuration
- Data Compilation
- Version Management
- Data Validation
- Data Submission
- Publishing & Labels
- Pre-built Training
- Lifecycle Management
Freyr UDI Features
- Freyr IDENTITY can be configured to GS1, ICCBBA, HIBCC Issuing Agencies (IAs) to issue respective Device Information (DI) formats
- Streamlines data management and source configuration through expert planning
- Identifies the authenticated data source through the highly qualified Regulatory team
- Captures, configures and manages all the critical 62 fields of Device Identifier (DI) attributes and 6 fields of Production Identifier (PI) attributes
- Efficient version control system to eliminate data redundancy and ensure accuracy
- Provides accurate data traceability and tracking across multiple lifecycles
- Powerful validator to eliminate errors and edits at each stage of submissions
- Generates XML submissions in HL7 Complaint SPL protocol
- Generates multiple reports on validated data
- Publishes final data to label printer in FDA approved format
- Processes the data for label printing in accordance with the AIDC & HRI