Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements.
Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the ...
Offering a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), and the ISO 9000 series, this book identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle.
Offering a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), and the ISO 9000 series, t...
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices.
Reliability engineering is an integral part of the product development process and of problem-solving...
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want...
