Verification & Testing Strategies for Compliance with ISO 13485:2016 & IEC 62304, 60601-1, 82304-1
Автор: Greenlight Guru
Загружено: 2024-01-19
Просмотров: 1523
Описание:
This on-demand webinar hosted by Greenlight Guru provides verification and testing strategies for medical device companies to comply with following international standards: ISO 13485:2016, IEC 62304, IEC 60601-1, and IEC 82304-1. It provides detailed guidance on ensuring medical devices meet these rigorous standards.
Main points covered:
1. Identifying medical devices that require verification testing and understanding the applicable standards.
2. Best practices and common mistakes in IEC 60601 testing for electrical medical devices.
3. Requirements for medical devices with software, ensuring compliance with IEC 62304 and IEC 82304.
4. Internal verification testing in line with FDA guidance, including test protocols and reports.
5. Utilizing a design traceability matrix to confirm completion of required testing.
Target Audience:
• Medical Device Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
Access the printable slides for this presentation here:
https://www.greenlight.guru/webinar/v...
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