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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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Showing 1 to 12 of 12 (1 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/ 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
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 Risk Management Following ISO 14971:2019

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Medical Device Risk Management Following ISO 14971:2019

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

$200.00
Medical Device Software Validation that Meets FDA Requirements

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Medical Device Software Validation that Meets FDA Requirements

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are developed and used in validation will be described.Learning ObjectivesSoftware validation is more than testingRequirements traceabilityRisk analysisUnit,..

$200.00
Preparing a FDA 510(k) Submission

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Preparing 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 s..

$200.00
Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience

CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry. The control of changes is one such topic that is complex. Lessons from practical experience show methods that will prevent a development program from becoming uncompli..

$200.00
Qualification of Suppliers and Contract Manufacturing Organizations

 Edwin Waldbusser
 Recorded Webinar
 60 Minutes
 Download Catalog
Qualification of Suppliers and Contract Manufacturing Organizations

Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppl..

Showing 1 to 12 of 12 (1 Pages)