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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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Showing 1 to 3 of 3 (1 Pages)
$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
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 3 of 3 (1 Pages)