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Speaker Profile
YUVAL SHAPIRO

Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries. More than 20 years of experience in QA; including MD&D RA & QA;QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000‎; EMC & Safety Certifications.


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$179.00
Cost of Quality

 Yuval Shapiro
 October 06 2022
 01 : 00 PM EST    
 60 Minutes
Cost of Quality

How could one assess the effectiveness of a Quality Management System?The best way to do that, is by using the ultimate transfer unit: MONEY!The purpose of a firm is to make Money, the purpose of a QMS is to enable the firm to produce, and therefore – generate money with minimum losses that are reflected by failures.The principles are known, but it is done?This lecture will give the listener the basic know-..

$179.00
Sample Size Selection

 Yuval Shapiro
 November 02 2022
 01 : 00 PM EST    
 60 Minutes
Sample Size Selection

Mr. Yuval Shapiro shall review the basic statistics that is behind the Sample Size selection. Explanations on how to select samples for design (verification and validation) phase, and for production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Areas Covered What is Sample Size and why is it important?Power AnalysisEstimation, Accuracy, PrecisionHypo..

$179.00
Robust CAPA Process for Medical Devices

 Yuval Shapiro
 December 07 2022
 01 : 00 PM EST    
 60 Minutes
Robust CAPA Process for Medical Devices

Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.) and the common practice.The difference between Correction, Corrective Action and Preventive Action will be discussed.Mr. Shapiro shall present common sources for CAPA, tools for root-cause-analysis, e.g. – 5 Why, Cause and Effect Diagram, Pareto Charts, etc.Also, w..

$179.00
EU Medical Devices Regulation: The Practice

 Yuval Shapiro
 January 25 2023
 01 : 00 PM EST    
 90 Minutes
EU Medical Devices Regulation: The Practice

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), incl..

$179.00
Risk Management - Implementing ISO14971: 2019

 Yuval Shapiro
 Feb 07 2023
 01 : 00 PM EST    
 60 Minutes
Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis.The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices product.This process has been streamlined within ISO14971 standard and has become the best practice to show application of risk-based approach implementation in th..

Showing 1 to 10 of 10 (1 Pages)
$200.00
EU Medical Devices Regulation: The Practice

 Yuval Shapiro
 Recorded Webinar
 90 Minutes
 Download Catalog
EU Medical Devices Regulation: The Practice

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), incl..

$200.00
New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation

Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical device products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementation..

$200.00
Risk Management - Implementing ISO14971: 2019

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of the Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management. Present some common errors when dealing with risk management. Present the new additions and changes to the new standard. Risk approach has become a mandatory practice during the Product Realization of Medical Devices. Th..

$200.00
Sample Size Selection: Is That Number Right?

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
Sample Size Selection: Is That Number Right?

Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..

$200.00
The New EU-Medical Devices Regulation (745/2017)

 Yuval Shapiro
 Recorded Webinar
 90 Minutes
 Download Catalog
The New EU-Medical Devices Regulation (745/2017)

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (M..

Showing 1 to 10 of 10 (1 Pages)