Showcase your brand and your regulatory compliance with clear, effective labeling.
Proper labeling is critical for medical device manufacturers, especially in the global market. To ensure regulatory compliance, patient safety, even brand equity, organizations must be sure all labeling documentation complies with current product standards for each country distributing their devices — which can be challenging in an ever-changing regulatory environment.
Wipro has a deep understanding of the global medical devices market, demonstrated expertise in regulatory services, and dedicated intelligence teams who continuously monitor changes in regulations worldwide to ensure we remain up to date. Working closely with regulatory teams, our comprehensive labeling and artwork services handle everything from assessing, updating, reviewing, tracking and maintaining label changes to be sure all our clients’ products comply with global and regional regulations.
- Artwork development
- UDI implementation
- IFU preparation, remediation, maintenance
- Labelling services
Creation, translation, regulatory compliance, managing warnings/precautions
- Creating, updating, and managing company core data sheet (CCDS)