This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.

Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit.

Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to

prepare for an FDA audit

identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies

determine the compatibility of design specifications and manufacturing, installation, and servicing demands

ensure that proper design, function, and performance stipulations are understood and met

verify and validate design criteria and production schemes

eliminate confusion and prevent communication breakdowns

allocate and conserve resources

perform risk assessment analyses

predict potential hazards under normal and fault conditions

Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Approaching design control as a mandated regulation for the medical device industry in the United States, consultants Teixera and Bradley offers advice on harmonizing product development models with the requirements of the U.S. Food and Drug Administration (FDA). They discuss the development of products in a step-by-step fashion, moving from design and development planning; through review, verification, and validation; to dealing with an FDA audit.
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Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly.