Speaker Profile


Edwin Waldbusser

Regulatory Consultant

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 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. 

21 CFR Part 11 Conformance for Medical Devices
21 CFR Part 11 Conformance for Medical Devices

Speaker:Edwin Waldbusser
Time: 8th January 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9085

Tue
08
Jan 2019

Hazard Analysis Following ISO 14971
Hazard Analysis Following ISO 14971

Speaker:Edwin Waldbusser
Time: 27th March 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9087

Wed
27
Mar 2019

How to Prepare for and Host FDA Inspection and Avoid 483s
How to Prepare for and Host FDA Inspection and Avoid 483s

Speaker:Edwin Waldbusser
Time: 10th September 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : MDAQ-9245

Tue
10
Sep 2019

Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Speaker:Edwin Waldbusser
Time: 26th April 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : MDAQ-9244

Fri
26
Apr 2019

Medical Device Software Validation: Meeting FDA Regulations
Medical Device Software Validation: Meeting FDA Regulations

Speaker:Edwin Waldbusser
Time: 25th July 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9086

Thu
25
Jul 2019

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