Overview

The webinar offers a comprehensive introduction to the ISO 13485:2016 standard, tailored for professionals in the medical device industry. The session delves into the core principles, requirements, and benefits of implementing a robust Quality Management System (QMS) compliant with ISO 13485. The webinar emphasizes the standard's role in ensuring the safety and effectiveness of medical devices, highlighting essential elements such as documentation, risk management, and process controls.

Participants will gain insights into the critical aspects of ISO 13485, including the necessity for thorough documentation and record-keeping, the importance of top management's commitment to the QMS, and the need for adequate resources and training to support the production of safe and effective medical devices. The session also provides practical tips and timelines for initiating the journey towards ISO 13485 certification, making it an invaluable resource for organizations aiming to enhance their quality management practices and comply with regulatory requirements.

Key takeaways and learning objectives

• An understanding of ISO 13485: Get to know the purpose and scope of the standard.
• Why it’s critical for ensuring the safety and effectiveness of medical devices.
• Learn about the key elements, including documentation, risk management and process controls.
• Discover practical tips and timelines for starting your journey towards ISO 13485 certification.

Presenter information

Greg Jones

Head of Assessment Delivery, Regulatory Services, BSI