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In this in-depth video, we explore the scope of ISO 13485, the international standard for quality management systems in the medical device industry. Learn how ISO 13485 applies to manufacturers, suppliers, and service providers and how it aligns with regulations like the FDA QSR and EU MDR.

What You’ll Learn:

* ISO 13485 Scope Overview: Discover how ISO 13485 impacts the design, development, production, and servicing of medical devices.
* Real-World Compliance Examples: Learn how companies have improved their quality management systems by implementing ISO 13485.
* Global Market Access: Understand how ISO 13485 certification is essential for accessing key markets like the EU, U.S., and Canada.
* Practical Implementation Steps: Gain insights into how to conduct a gap analysis, implement risk management, and use the PDCA cycle for continuous improvement.
* Compliance and Risk Management: Explore the importance of aligning ISO 13485 with local regulations and how risk management plays a critical role.
Learn more about ISO 13485 at [ Ссылка ]

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