Quality Management System for Medical Devices-ISO 13485

What you’ll learn:
Identify and explain the key requirements of the standard, including its structure, core principles (risk-based approach, process approach).
Develop the ability to apply ISO 13485 concepts to practical situations within medical device companies, using real-world examples and scenarios.
Gain the knowledge and tools to design, implement, and maintain an effective QMS that aligns with ISO 13485, including developing quality documentation.
Understand how ISO 13485 contributes to the development and delivery of safe and effective medical devices, recognizing its role in minimizing risks.

Requirements:
No experience or prior curriculum required

Description:
This comprehensive video course provides a deep dive into the requirements of ISO 13485:2016, the international standard for quality management systems in the medical device industry. Through engaging lectures, real-world examples, and clear explanations, you’ll gain a practical understanding of how to build, implement, and maintain a robust QMS that meets the rigorous demands of this critical field.Who Should Take This Course:Quality professionals working in medical device companiesRegulatory affairs personnelEngineers and designers involved in medical device developmentManagement and leadership teams responsible for qualityAnyone seeking to understand or implement ISO 13485What You Will Learn:The structure, core principles, and key requirements of ISO 13485:2016How to apply a risk-based approach and process approach to your QMSEssential QMS documentation, including the Quality Manual and Medical Device FilesManagement’s role in driving a culture of quality and ensuring complianceEffective resource management, including human resources, infrastructure, and work environmentThe stages of product realization, from design and development to purchasing, production, and post-market surveillanceKey tools for measurement, analysis, and improvement, including corrective and preventive actionBy the end of this course, you’ll be able to:Confidently navigate the requirements of ISO 13485:2016Apply its principles to practical scenarios in your organizationContribute to building and maintaining an effective medical device QMSEnhance your understanding of how quality management impacts medical device safety and effectivenessStart your journey towards medical device excellence today! Enroll in our Mastering ISO 13485:2016 course.

Who this course is for:
Medical Device Professional wanting to learn about ISO 13485 Standard for Quality Managament System.