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.
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..
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..
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..
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..
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..
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..
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..
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..