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Edwin Waldbusser

Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a 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 owner of www.meddeviceadvisors. com which offers over 80 easy to customize medical device Quality System SOP?s

 
   
Live Webinars   Recorded Webinars
No Recorded Webinars found
LSHCHEW003
07/12/2017
10:00 AM PST | 01:00 PM EST,
Duration 60 mins
Edwin Waldbusser  
How to Conduct a Human Factors/ Usability Validation Test following ISO 62366 and the 2016 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 rather than quantitative as is in device validation. Cla....

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$165 
Single Live
(Only for one Participant)
$335 
Multiple Single
( 2 - 5 Participants)
$670 
Corporate Live
( 6 - 10 Participants)
$193 
  Recorded
(6 months unlimited access)
 
LSHCMEW004
10/24/2017
10:00 AM PST | 01:00 PM EST,
Duration 60 mins
Edwin Waldbusser  
Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

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 just testing performance.
Cybersecuri....

View Details

$165 
Single Live
(Only for one Participant)
$335 
Multiple Single
( 2 - 5 Participants)
$670 
Corporate Live
( 6 - 10 Participants)
$193 
  Recorded
(6 months unlimited access)
 
LSHCHEW002
Duration 60 mins
View Anytime
recorded  
Human Factors/ Usability following ISO 62366 and 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 an....

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      Play      

$193 Recorded (6 months unlimited access)
 
LSHCEW002
Duration 60 mins
View Anytime
recorded  
How to Prepare a FDA 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 will be discussed. How to find an acceptable predicat....

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      Play      

$193 Recorded (6 months unlimited access)
 
LSHCCEW001
Duration 60 mins
View Anytime
recorded  
21 CFR part 11 Compliance - electronic records & electronic 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 will be explained. FDA regulated companies want to transi....

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      Play      

$193 Recorded (6 months unlimited access)
 
LSHCEW001
Duration 60 mins
View Anytime
recorded  
Hazard Analysis following ISO 14971

Designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data that the majority of recalls were due to a faulty design process. These recalled products wer....

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      Play      

$193 Recorded (6 months unlimited access)
 
LSHC0005
Duration 60 mins
View Anytime
recorded  
Human Factors /Usability Study based on ISO 62366 and latest 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 val....

View Details

      Play      

$193 Recorded (6 months unlimited access)
 
LSHC0004
Duration 60 mins
View Anytime
recorded  
How to Prepare for a FDA inspection and prepare response to 483's and warning letters.

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....

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      Play      

$193 Recorded (6 months unlimited access)
 
LSHCEW003
Duration 60 mins
View Anytime
recorded  
21 CFR part 11 Compliance - electronic records & electronic 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 will be explained. FDA regulated companies want to trans....

View Details

      Play      

$193 Recorded (6 months unlimited access)
 
 
 
 

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