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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

 Webinar Id: LSHCMEW004
10:00 AM PT | 01:00 PM ET
 10/24/2017
 Duration 60 mins

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. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.


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               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCMEW005
10.00 AM PT | 01.00 PM ET
 11/08/2017
 Duration 90 mins

Medical Device Premarket and Post market Cyber security following the new FDA Guidances

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices. All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to........


View Details

               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCMEW006
10.00 AM PT | 03:30 PM ET
 11/14/2017
 Duration 90 mins

MDR Program conforming to 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 death, injury and malfunction reporting requirements, record keeping requirements, report timing, clarification of the term "becoming aware" and clarification of reporting using electronic form 3500A.


View Details

               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCMEW007
10.00 AM PT | 01.00 PM ET
 12/04/2017
 Duration 90 mins

Conducting a Software Validation of Medical Device to Meet FDA Requirements

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.


View Details

               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCHEW003
 View Anytime
 Duration 60 mins

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. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCHEW002
 View Anytime
 Duration 60 mins

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 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 new ISO 62366 standard and the........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCEW002
 View Anytime
 Duration 60 mins

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 predicate device will be taught. FDA places special emphasis on device software. we will cover the requirements for software.

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCCEW001
 View Anytime
 Duration 60 mins

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 transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records f........

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCEW001
 View Anytime
 Duration 60 mins

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 were tested before release and later found to fail in unanticipated ways that were not considered in the testing process. FDA also concluded th........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHC0005
 View Anytime
 Duration 60 mins

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 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 new ISO 62366 standard and the........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHC0004
 View Anytime
 Duration 60 mins

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, the inspection process and how to respond to 483's and warning letters.

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCEW003
 View Anytime
 Duration 60 mins

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 transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records f........

$ 237  Recorded  (6 months unlimited access)

View Details

    
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