If you are doing business in the EU, then you should purchase this version of the standard. The EN version of the standard introduces three new annexes which have their own set of requirements. Everywhere else in the world ISO 14971:2019 remains the current standard. EN is the ISO standard for the European market. It is paramount for your organization to guarantee that your products are safe and effective, and having a risk management system in place is crucial. Additionally, ISO 14971 provides a thorough explanation of terms and definitions. This standard defines the best practices throughout the entire life cycle from design to distribution and maintenance. ISO 14971 addresses risk management and is the international standard designed for the medical device industry. ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.
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