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.

27 results Found
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This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.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
Recorded Webinar

Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how users 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 eff ...

  • Basic & Intermediate
  • 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 regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Free Webinar

Medical Device Cyber-security following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communi ...

  • Basic & Advanced
  • 60 Mins
Free Webinar

Human Factors/ Usability Studies following ISO62366 and the New FDA 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 & Intermediate & Advanced
  • 60 Mins
Free 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
Free Webinar

Mobile Medical Apps(is it a FDA regulated device) and Cyber Security

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than j ...

  • Intermediate
  • 60 Mins
Free Webinar

How to Conduct a Human Factors/ Usability Validation

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. For example, success criteria is qualitative rather than quan ...

  • Intermediate
  • 60 Mins
Recorded Webinar

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. The phases of the selection process, from compiling a list of candidate developers through the qualificatio ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

Medical Device Complaints & CAPA

This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be disc ...

  • Basic & Intermediate & Advanced
  • 60 Mins