Quality Assurance and Regulatory Affairs
Medical Device Labeling & Packaging
Ensuring End-To-End Packaging & Labeling Compliance
In major markets, compliance with packaging and labeling standards is essential to market approval and long-term success. Errors in labeling and packaging are among the leading causes of medical device recalls, significantly impacting patient safety and brand trust. To address these issues, manufacturers are adapting to increasingly complex and frequently updated global regulations.
Effective medical device labeling and packaging must preserve product integrity and communicate safety information with clarity. Meeting international standards such ISO 15223-1, ISO 18113 series and Unique Device Identification (UDI) regulations is vital for global market access and traceability.
Our deep expertise and advanced infrastructure ensure your medical device packaging and labeling are fully compliant and user-centric. Our streamlined processes reduce time-to-market and prevent delays in product launches or rebranding.
Our Key Capabilities
Labeling Strategy & Standardization
End-to-end global labeling strategy aligned with ISO 15223-1 and UDI requirements
Content management and localization for all labeling elements
Automation to improve output, reduce human error, and lower costs associated with mislabeling or recalls
Customization of primary and secondary label content
Complete data security, privacy, and traceability in labeling operations
Label accuracy and consistency throughout the supply chain
Labeling Compliance & Regulatory Localization
Compliance with 21 CFR 801, EU MDR, and IVDR requirements
IFU (Instructions for Use) in multiple languages
Label gap analysis and regulatory updates based on national standards
Use of internationally recognized symbols
Labeling Lifecycle Management
Creation, remediation, and maintenance of label components
Labeling verification and validation
Change management
Regulatory updates integration
Patient & Market-Centric Support
Development of multi-language patient guides and safety leaflets
User-centered labeling and packaging designs
QMS integration throughout the product lifecycle
Sustainable & Compliant Packaging Solutions
Design and Development of Regulatory-Compliant Packaging Systems
Implementation of Sustainable and Eco-Friendly Packaging Strategies
Comprehensive Packaging tests Validation
(including leak integrity, compression, vibration, stability, and accelerated/real-time aging tests)