Mr. Edwin Waldbusser

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Profile

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.

14 results Found
On-Demand 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 rat ...

  • Basic & Advanced
  • 60 Mins
On-Demand Webinar

Human Factors/ Usability Studies 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. For example, success criteria is qualitative rat ...

  • Basic & Advanced
  • 60 Mins
Recorded Webinar

HAZARD ANALYSIS Following ISO14971

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 recognized standard. One of the techniques described in I ...

  • Intermediate
  • 60 Mins
Recorded Webinar

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

In this web session you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of m ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

Medical Device Cybersecurity: Following New FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks mu ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

Human Factors and Usability Studies following ISO 62366 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 vali ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

21 CFR Part 11 Compliance

This session 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 will ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

How to Prepare a 510(k) Submission

We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Human Factors and Usability Studies following ISO 62366 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 vali ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

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

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock ...

  • 60 Mins