Regulatory Affairs Professional Society Session:
Challenges and Best Practices with International Labeling and Language Compliance
26 October 2010
Medical device manufacturers face an array of challenges in delivering products to international markets. Complying with diverse and evolving regulatory requirements that vary by region, providing country-specific translations, and ensuring compliance and consistency throughout the global supply chain are critical to successful labeling processes.
With risks to patient safety, regulatory review, and ultimately brand equity, organizations must ensure that labeling processes comply with the then-current standards of each country distributing their devices. It is also incumbent upon these organizations to adopt practices that enable them to react quickly to process change requirements.
This presentation provides an overview of language compliance and labeling considerations for medical devices marketed and sold in the EU/EEA. In addition, you will learn about best practices to address common challenges and to prepare for a successful product delivery. If you are a regulatory professional, technical writer, translation manager, software developer or involved in global communications, please attend this event to learn more about the challenges and best practices for language and labeling compliance.
Join our presentation to learn about:
- How to handle periodic changes in compliance standards with minimal impact to your organization.
- How to implement a system that integrates with your corporate data and applications.
- How to quickly validate translation changes with dynamic template-driven processes.
- How to implement product delivery processes that comply with regulatory agencies such as FDA, GHTF, GS1, Eucomed, EMEA, and PMDA.
- How to produce documents that comply with country-specific requirements.