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.prepare for an FDA audit
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
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.
Table of Contents
Overview; design and development planning; design input I; design input II; design outputs; design review; design verification; design validation; process validation; design transfer; design changes; the design history file; questions to expect in an audit.