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Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485
(Polytechnic University of Puerto Rico, 2010)
This paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes ...
Reduce Scrap Loss of a Pacemaker Lead Applying Lean-Six Sigma
(Polytechnic University of Puerto Rico, 2010)
A pacemaker is an electronic device that is placed under the skin to help control abnormal heart rhythms. It consists of a battery, a computerized generator, and lead (wires) with electrodes on one end. in a pacemaker leads ...
Faster Sample Delivery to the Microbiology Laboratory using Lean Six Sigma
(Polytechnic University of Puerto Rico, 2010)
This article presents the Lean Six Sigma tools used to identify the factors that impact the timely arrival of environmental water samples to a Microbiology Laboratory in a biotechnology industry. The inherent variations ...