Mr.Edwin Waldbusser

This course will explain the FDA QMSR that is effective February 2026, replacing the QSR.  The integration of ISO 13485 into 21 CFR Part 820 to form the QMSR will be explained. The QMSR isn’t only a revision. It changes the approach to a Quality System. It al ...

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation and how to use ISO62304 to establ ...

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...