Скачать или смотреть Mastering MedTech Compliance: How Pure Global Redefines ISO 13485 and ISO 14971 Consulting for Gl...

This episode of MedTech Global Insights delves into the critical challenges of maintaining ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management) compliance while scaling into global markets. We move beyond the basics of certification and explore why a fragmented, market-by-market approach to regulatory compliance is no longer viable in the fast-paced MedTech industry.

We uncover how a modern, integrated platform approach, leveraging AI and unified global expertise, can transform your quality and risk management from a costly burden into a strategic asset. This method allows MedTech innovators to use a single, core set of documentation to efficiently access dozens of international markets, saving critical time and resources.

Consider this case: A promising European MedTech company with full CE marking is ready for global expansion. Their roadblock? Adapting their pristine quality and risk management systems for the unique and divergent demands of the FDA in the U.S., ANVISA in Brazil, and the MFDS in South Korea. This episode dives into how they can overcome this costly and time-consuming hurdle, turning a multi-year, multi-team challenge into a streamlined, centrally managed process.

In this episode, you'll discover:
1. Why is simply being "ISO 13485 certified" not enough for sustainable global market entry?
2. How can your ISO 14971 risk management file become a strategic tool rather than just a regulatory document?
3. What is the "single process, multiple markets" strategy and how can it drastically cut your time to market?
4. How is AI transforming the management of quality systems and technical dossiers for global submissions?
5. What are the most common and costly pitfalls when scaling a MedTech QMS from one country to ten?
6. How can you ensure your post-market surveillance activities satisfy regulators in Europe, the Americas, and Asia simultaneously?
7. What capabilities should you demand from a modern regulatory consulting firm beyond just local knowledge?

Contact us at [email protected] or visit https://pureglobal.com/