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.

23 results Found
On-Demand 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 fo ...

  • Basic & Advanced
  • 60 Mins
On-Demand 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, a ...

  • Basic & Intermediate & Advanced
  • 60 Mins
On-Demand 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 requiremen ...

  • Intermediate
  • 60 Mins
On-Demand 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 m ...

  • Intermediate
  • 60 Mins
Recorded 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 qualitat ...

  • 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 thro ...

  • Basic & Intermediate & Advanced
  • 60 Mins
On-Demand 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 fo ...

  • Basic & 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 neglec ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

21 CFR Part 11 Conformance for Medical Devices

Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its co ...

  • Basic & Advanced
  • 60 Mins
On-Demand 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, a ...

  • Basic & Advanced
  • 60 Mins