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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
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market

 Yuval Shapiro
 March 23 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market

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
Sample Size Selection: Is That Number Right?

 Yuval Shapiro
 April 21 2021
 01 : 00 PM EST    
 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..

$179.00
Production Process Validation: A Short Hitchhiker’s Guide

 Yuval Shapiro
 May 11 2021
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Production Process Validation: A Short Hitchhiker’s Guide

Process Validation in the Medical Device industry is a a vitally important component of your Quality Management System. While reasonably straightforward in principle, a poor implementation may lead to uncertainty which in the worst case can result in costly field actions. So how do you determine which process to validate and what are the keys to good process validation?In this the session, Mr. Yuval Sha..

Showing 1 to 10 of 10 (1 Pages)
$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..

$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 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. This p..

$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
Design And Development for Medical Devices

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
Design And Development for Medical Devices

Mr. Yuval Shapiro shall present the requirements for design and development as per medical devices standards (ISO13485), and some common practices. What is the V-model? How is it applied in Medical Devices?What is the required documentation for the design and development of medical devices?What is verification in contrast to validation? Could those be combined?How changes should be managed?Medical Devices c..

$200.00
Robust CAPA Process for Medical Devices

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
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. – 5Why, Cause, and Effect Diagram, Pareto Charts, etc. Als..

$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 devices products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementatio..

$200.00
Cost of Quality

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Download Catalog
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-h..

Showing 1 to 10 of 10 (1 Pages)