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This short book is a starting point to introduce Design control, risk management and regulatory impact and application of Medical Device Directive MDR 2017/745
DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
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This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive
Design Controls for the Medical Device Industry
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This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 an
Design Controls for the Medical Device Industry, Third Edition
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Reliable Design of Medical Devices
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As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable