Comprehensive Overview: Understand the nuances of ISO 14971:2019, focusing on risk management application for medical devices and highlighting key differences from the 2012 version.
Key Learning Objectives: Learn to identify essential elements crucial for medical device risk management as outlined in ISO 14971:2019. Understand the significant changes introduced in the third edition. Acquire skills to assess the lifecycle stage of medical devices and perform product risk assessments.
Usability Focus: Grasp the specific risk management requirements related to usability, ensuring a holistic approach to product safety and effectiveness.
Directive Comparison: Differentiate between directives and EN ISO 14971:2012 (Annex Z). Understand the continued applicability of these standards and why they are essential in the evolving landscape of medical device regulations
For in-depth insights into our ISO 14971:2019 Risk Management for Medical Devices Introduction Course, fill in the form to elevate your expertise in this critical aspect of medical device compliance.
ISO 14971:2019 Risk Management for Medical Devices Introduction
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