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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
Design And Development for Medical Devices

 Yuval Shapiro
 June 24 2020
 01 : 00 PM EST    
 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..

$179.00
Robust CAPA Process for Medical Devices

 Yuval Shapiro
 June 25 2020
 11 : 30 AM EST    
 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..

$179.00
Irradiation Sterilization: How to Avoid Rejections

 Yuval Shapiro
 July 16 2020
 01 : 00 PM EST    
 60 Minutes
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Irradiation Sterilization: How to Avoid Rejections

Mr. Yuval Shapiro shall present the requirements for irradiation sterilization medical devices standards (ISO11137 Family etc.), and some common practices.When one should apply irradiation sterilization?What kind of verification and validations should be done?How to present to Notified Body the process and information?Many Medical Device companies are required to establish and maintain structured processes ..

Showing 1 to 8 of 8 (1 Pages)
$200.00
The New EU-Medical Devices Regulation (745/2017)

 Yuval Shapiro
 Recorded Webinar
 90 Minutes
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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
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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
Cost of Quality

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
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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..

$200.00
Sampling Size

 Yuval Shapiro
 Recorded Webinar
 60 Minutes
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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..

$200.00
EU Medical Devices Regulation: The Practice

 Yuval Shapiro
 Recorded Webinar
 90 Minutes
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 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..

Showing 1 to 8 of 8 (1 Pages)