Title :
Regulatory issues [what is the QSR/GMP, and why should you care?]
Abstract :
Mention good manufacturing practice (GMP) or quality system regulation (QSR) and many engineers will immediately think of mounds of questionably meaningless paperwork. Is that really what the QSR is about? Or is that impression brought about by bad implementations of the QSR and a lack of understanding as to why medical manufacturers need the QSR? This article gives more of an overview as to what the key ideas are behind the QSR.
Keywords :
biomedical equipment; product design; product liability; quality management; control and feedback loop; design control; good manufacturing practice; medical device manufacturers; quality system regulation; redesign cycles; testing; verification; Assembly; Biomedical engineering; Control systems; Documentation; Error analysis; Feedback loop; Manufacturing processes; Pulp manufacturing; Standards publication; System testing; Equipment and Supplies; Mandatory Reporting; Product Surveillance, Postmarketing; Quality Assurance, Health Care; United States;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
DOI :
10.1109/MEMB.2004.1310998
