Speaker Profile
Edwin Waldbusser
Regulatory Consultant, Med Device Advisors, Founder,Medical Device SOP Advisors,LLC-offering 82 SOP's,
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
- 9
- March
- 2021
- Tuesday
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $149.00
| View Details
- 17
- March
- 2021
- Wednesday
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Edwin Waldbusser |
Duration:60 Minutes |
Price: $149.00
| View Details
- 25
- March
- 2021
- Thursday
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Edwin Waldbusser |
Duration:60 Minutes |
Price: $149.00
| View Details
Medical Device Risk Management following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Medical Device Risk Management following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
Medical Device Hazard analysis following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details