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Edwin Waldbusser

Founder, Medical Device Advisors LLC

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.



  •  Tuesday, January 29, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Qualification of Contract Software Developers Based on Practical Experience

This webinar will explain the regulatory requirements and a risk-based procedure to qualify and manage suppliers that develop software for your company.

  •  Wednesday, February 13, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

  •  Tuesday, February 26, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

  •  Wednesday, March 13, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.





  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Qualification of Contract Software Developers Based on Practical Experience

This webinar will explain the regulatory requirements and a risk-based procedure to qualify and manage suppliers that develop software for your company.

  • Recorded
  • View Anytime
  • ¤190.00
Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.