Learn how to interpret the 13485 Standard and apply it to your own organization. This course prepares you to perform effective audits of Medical Device Quality Management Systems. Within…

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge…

This seminar fully covers the ISO 13485:2016 requirements. Auditing topics from ISO 19011 such as the auditing process and methodologies, e. g. planning and conducting an audit,…

Learn the application of the FMEA approach to ISO 14971:2019 Application of Risk Management to Medical Devices, and be able to define the use of DFMEAs as a process within your…

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge…

Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, a…

Understanding MDSAP training course will teach students to plan, develop and implement a QMS in accordance with MDSAP and ISO 13485:2016 requirements. Considering the ISO 13485:2016…