Mr.Edwin Waldbusser

Area Of Expertise : MD Device Control, Software validation
30 Years Of Experience
Training Industry : Hospital & Healthcare

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.

31 results Found
Live Webinar

FDA Regulation of Artificial Intelligence - Machine Learning

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

  • Basic & Intermediate
  • 60 Mins
  • Feb 29, 2024
Live Webinar

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". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...

  • Intermediate
  • 60 Mins
  • Mar 14, 2024
Live Webinar

FDA Regulation of Artificial Intelligence/ Machine Learning

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 ...

  • Basic & Intermediate & Advanced
  • 60 Mins
  • Mar 29, 2024
Recorded Webinar

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

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 ...

  • Basic & Advanced
  • 60 Mins
On-Demand Webinar

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. Procedures for controlling electronic signatures and electronic records as described in ...

  • Basic & Advanced
  • 60 Mins
Recorded Webinar

Medical Device Software Validation Meeting FDA Regulations

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 ...

  • Basic & Advanced
  • 60 Mins
On-Demand Webinar

How to Prepare for and Host an FDA Inspection and respond to 483s

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, ...

  • Basic & Advanced
  • 60 Mins
On-Demand Webinar

FDA Regulation of Artificial Intelligence - Machine Learning

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

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

How to get a 510(k) for a Machine Learning Product

We will explain what a 510(k) is and explain the other FDA regulatory pathways. We will discuss how software can be considered a device by the FDA.  The procedure to obtain a 510(k) will be explained.  The contents of the submission to the FDA will be explain ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualita ...

  • Basic & Advanced
  • 60 Mins