The PTC UDI Solution Accurately Tracks All Submissions To The FDA As Well As Communications From Them (Graphic: Business Wire)
PTC (Nasdaq: PMTC) today announced the availability of the latest release of PTC Windchill® product lifecycle management (PLM) software. PTC Windchill 10.2 adds capabilities to help manufacturers improve productivity and streamline compliance with new government regulations.
Streamline ComplianceWith FDA regulated Unique Device Identification (UDI) compliance set to take place during 2014, medical device manufacturers need a solution that will reduce the effort needed to comply with the law. The regulation specifically mandates that every unique product, product version, and product configuration be assigned a UDI to be prominently displayed on its labeling.
In requiring medical device manufacturers to provide UDI-compliant labeling, the new regulation presents them with the significant challenge of efficiently handling the vast amounts of data required for UDI-compliant submissions for each and every product, including unique product versions, variants, configurations, and packaging.
As a result, PTC has developed a preconfigured, out-of-the-box technology solution, PTC UDI, to provide for the complete management and traceability of UDI data while retaining the flexibility needed to scale to future regulatory and product development changes. This includes:
- Collecting and Managing key UDI data from multiple data stores
- Automating the submission process with out-of-the-box review and approval workflows and pre-submission data validation algorithms identical to those used by the FDA;
- Streamlining the management of UDI data, both to accommodate product versions/variants and to meet the needs of future regulatory requirements from the FDA and other global agencies.
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