Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

Upcoming Webinars by this speaker Recorded Webinars by this speaker Back to Our Speaker
Edwin Waldbusser

07
Wed
Jun, 2017

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700675

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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 recommends using ISO 14971 as a guide and has accepted it as a recognimore...

Edwin Edwin

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700649

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How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation more...

Edwin Edwin

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700486

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How to prepare for and host a FDA inspection and respond to 483’s

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483 warning letter than a disorganized company. more...

Edwin Edwin

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700437

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Human Factors and Usability Studies

Human Factors Usability is the analysis of how people interact with medical devices and medical device risk analysis. The various types and methods of human factors analysis will be explained. This more...

Edwin Edwin

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700286

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21 CFR Part 11 Compliance

This Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling el more...