Labeling, UDI, ISO 15223-1, 21 CFR 801 Compliance Consultants

Deep Dive into ISO 15223-1 and 21 CFR 801 830

ISO 15223-1 Mastery: This standard provides a harmonized approach to medical device labeling, specifying symbols and terminology that can be universally understood. However, integrating these symbols into product labels and instructions for use (IFU) requires a nuanced understanding of both the standard and its application in diverse regulatory environments. MedLaunch provides strategic guidance to translate requirements into labeling that aligns with regulations and promotes clear comprehension and safe use.

21 CFR 801 & 830 – A Closer Look: The FDA’s regulations for labeling and UDI pose unique challenges, from determining the appropriate symbols and labeling content to managing the complexities of UDI integration into global distribution networks. MedLaunch’s expertise shines in demystifying these regulations, offering solutions that align with your operational workflows and market objectives.

Mastering UDI Compliance for Global Traceability

The Unique Device Identification (UDI) system, as outlined in 21 CFR 830, is crucial for the traceability and post-market surveillance of medical devices. Implementing a UDI system involves understanding complex regulatory requirements and integrating them into your product labeling and data reporting processes.

MedLaunch provides a comprehensive suite of services to help you seamlessly transition to UDI compliance, including:

• UDI Strategy and Implementation: We help you develop a clear roadmap for UDI compliance, addressing technical, operational, and regulatory considerations to facilitate smooth integration into your existing quality management and production systems.
• Data Management and Submission Support: Managing UDI data across different jurisdictions can be complex. MedLaunch provides structured support in organizing, validating, and submitting UDI data to global databases, maintaining precision and timeliness in compliance reporting.
• Continuous Education and Compliance Monitoring: As regulations evolve, so do the requirements for labeling and UDI compliance. MedLaunch stays ahead of regulatory changes, providing ongoing education, updates, and support to ensure your compliance strategies remain effective and current.

Begin your journey to flawless medical device labeling and comprehensive UDI compliance with MedLaunch. Contact us today to explore how we can elevate your compliance strategy and help your devices stand out for their quality, safety, and global accessibility.