FDA UDI, EU MDR, FDA PART 11, EU Clinical trials
regulations can be easily implemented with the right
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ACHIEVING REGULATORY COMPLIANCE
The regulatory requirements for the life sciences industry create specific operating challenges. All label and artwork production systems and processes/output need to comply with regulations for each country or region in which products are supplied.
Changing regulations, such as evolving UDI, EU MDR and the EU clinical trial regulations, need to be incorporated into these label and artwork processes appropriately, and in time for when the regulation takes effect.
Finally, the label and artwork systems and operating procedures are subject to audit by regulators to ensure compliance.
How we helped one of our clients with this challenge:
- Tier 1 Global Medical Device manufacturer
- Experienced issues with incorrect data on production labels which resulted in multiple recalls
- Implemented our enterprise label lifecycle management solution
- Automated label production with integrated data feeds and handling data once! Giving one source of the truth
- Achieved zero-defect labels with full compliance and realized $19m savings in
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This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.
REGULATORY AND COMPLIANCE LABELING RESOURCES
Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about what the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) mean for labels in this free webinar.
EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.