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Medical Device Quality Assurance and Regulatory Compliance

Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents;

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Medical Device Quality Assurance and Regulatory Compliance

Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents;

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Medical Device Quality Management Systems

of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient;

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Pharmaceutical Dosage Forms

, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US;

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Quality Assurance

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance;

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Medical Device Regulatory Practices

consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major;

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Handbook of Medical Device Regulatory Affairs in Asia

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put;

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21 CFR Part 11

technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the;

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21 CFR Part 11

technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the;

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Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put;

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Cost-Contained Regulatory Compliance

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory;

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Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and;

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Cybersecurity for Connected Medical Devices

Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality;

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Medical Device Regulations

In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has;

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A Simple Guide to Understanding Medical Device Regulations

, their regulatory systems have proven to be ineffective in quality management and in monitoring the domestic market to prevent unsafe and low;

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FDA Regulatory Affairs

Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time;

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Compliance Assurance for the Safe Transport of Radioactive Material

transport of radioactive material. It also provides guidance to applicants, licensees and operating organizations for their interactions with;

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Medical Regulatory Affairs

countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Experts from;

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Foundations and Strategies for Medical Device Design

communicating and understanding the scientific, regulatory, and business aspects of medical device design. Foundations and Strategies for Medical;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

This book highlights the challenges facing quality assurancequality control (QA/QC) in today's biopharmaceutical environment and presents;

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Medical Device Safety

proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.;

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The Handbook of Patient Safety Compliance

organizations in patient safety * Failure modes and effect analysis * Voluntary and regulatory oversight of medical error * Evidence-based outcomes and;

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Medical Device Reliability and Associated Areas

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its;

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Medical Device Reliability and Associated Areas

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its;

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Humanizing Healthcare Human Factors for Medical Device Design

regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and;

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Humanizing Healthcare - Human Factors for Medical Device Design

regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and;

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FDA Regulatory Affairs

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain;

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