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Speaker Profile
EDWIN WALDBUSSER

Edwin retired from the industry after 30 years in management of the development of medical device products and the development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems, and inhalation devices. His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control, and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with an emphasis on design control, software validation, risk analysis, and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and an M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents. He is also an owner of www.meddeviceadvisors.com which offers over 80 easy to customize medical device Quality System SOP's.


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$179.00
FDA Regulation of Artificial Intelligence/Machine Learning

 Edwin Waldbusser
 April 22 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
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 software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following de..

$179.00
Medical Device MDR following new FDA Guidance

 Edwin Waldbusser
 May 11 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Medical Device MDR following new FDA Guidance

This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, recordkeeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.Learning ObjectivesMDR regulation, reporting requirements, report timing, when do you..

$179.00
How to Conduct a Human Factors/Usability Validation

 Edwin Waldbusser
 June 15 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
How to Conduct a Human Factors/Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positiv..

$179.00
Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

 Edwin Waldbusser
 July 22 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

This course will explain how to manage a design program that will meet FDA requirements and minimize the chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget. The important and confusing question of when, in a development process, Design Control begins will be answered. The differences be..

Showing 1 to 15 of 21 (2 Pages)
$150.00
BEST SELLER - Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The..

$150.00
BEST SELLER - Medical Device - Engineering change control

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - Medical Device - Engineering change control

Companies need to be able to adapt quickly in today’s constantly changing environment, and often that means making changes to their products. Engineers make modifications during development and production with the intent of adding functionality, improving manufacturing performance or addressing the availability of a particular part. To make sure proposed changes are appropriately reviewed, a solid process i..

$150.00
BEST SELLER - Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

The FDA has released a Guidance explaining how they intend to apply their regulatory authority to software applications intended for use on mobile platforms. They have defined what types of apps they consider a medical device. Apps that are medical devices must meet all FDA device requirements, however, FDA will not enforce their requirements on Mobile apps that meet the FDA’s definition of a medical device..

$200.00
21 CFR Part11 Compliance

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
21 CFR Part11 Compliance

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 will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..

$200.00
How to Prepare for and Host a FDA Inspection and Respond to 483’s

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
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 audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically impo..

$200.00
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required the number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test...

$200.00
Human Factors/ Usability following ISO 62366 and new FDA Guidance

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Human Factors/ Usability following ISO 62366 and new FDA Guidance

Human Factors/Usability is an analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating results with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to t..

$200.00
Human Factors/Usability Studies following ISO62366 and the new FDA Guidance

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
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 effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the n..

$200.00
Medical Device - Engineering change control

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Medical Device - Engineering change control

Companies need to be able to adapt quickly in today’s constantly changing environment, and often that means making changes to their products. Engineers make modifications during development and production with the intent of adding functionality, improving manufacturing performance or addressing the availability of a particular part. To make sure proposed changes are appropriately reviewed, a solid process i..

$200.00
Medical Device Complaints and Corrective and Preventative Action (CAPA)

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Medical Device Complaints and Corrective and Preventative Action (CAPA)

Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is str..

$200.00
Medical Device Hazard Analysis following ISO 14971

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
Medical Device Hazard Analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques becau..

Showing 1 to 15 of 21 (2 Pages)