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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 Rush for ISO13485: 2016

 Yuval Shapiro
 June 25 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
The Rush for ISO13485: 2016

In this session, Mr. Shapiro will provide an overview of the history of the ISO13485 and the newly introduced changes. He will also discuss how the changes interact with regulatory requirements, and how to face the new changes. The webinar will focus on key provisions and considerations when establishing a QMS as per the ISO13485: 2016,  and identify pitfalls that should be avoided.On March 2016 ISO – ..

$179.00
Sampling Size

 Yuval Shapiro
 July 24 2019
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Sampling Size

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. Selection of the correct sample size is a challenging task, especially, when regulatory authorities require..

$179.00
The New EU-Medical Devices Regulation (745/2017)

 Yuval Shapiro
 September 19 2019
 01 : 00 PM EST    
 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 (MDR), incl..

Showing 1 to 4 of 4 (1 Pages)
$200.00
Cost of Quality

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
 Refer a Friend
 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 4 of 4 (1 Pages)