Lecture 2--Apr 6---Taylor (1)

Lecture 2--Apr 6---Taylor (1) - Center for Devices and...

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Unformatted text preview: Center for Devices and Radiological Health U. S. Department of Health and Human Services Design Control Principles Product Development For Medical Applications (BME 480/680) School of Biomedical Engineering, Science, and Health Systems Drexel University April 6, 2011 Center for Devices and Radiological Health Who am I? Alford R. Taylor, Jr. Director, Division of Electrical and Software Engineering Office of Science and Engineering Laboratories WO62-4214 10903 New Hampshire Ave Silver Spring MD 20993-0002 [email protected] (301) 796-2583 Assistance is also available from the Division of Small Manufacturers, International and Consumer Assistance, http://www.fda.gov/cdrh/industry/support. You don’t have to be a small manufacturer to avail yourself of this service! Center for Devices and Radiological Health Today’s Agenda DESIGN CONTROLS Why all the fuss? What are design controls? What do they do? How do they work? PRODUCT QUALITY What do we mean by “quality”? How does one systematically manage product quality? Center for Devices and Radiological Health The Reviewer’s Challenge Does it work? How does it work? How well does it work? How well does it need to work? Center for Devices and Radiological Health The Reviewer’s Challenge Does it work? How does it work? How well does it work? How well does it need to work? — or — How bad can it be and still be acceptable? Center for Devices and Radiological Health How Well Does It Need to Work? FASTER BETTER CHEAPER MARS CLIMATE ORBITER . 54 . 2 . 1 cm in = NASA Philosophy 1992—2002 Center for Devices and Radiological Health It’s Good Enough if . . . . . . design and manufacturing processes are grounded in quality management and risk management standards (e.g., ISO 9001 and 14971), and design decisions are based on scientific and engineering principles, as evidenced by textbooks, professional literature, consensus standards, past experience. Center for Devices and Radiological Health Which Product Has Higher Quality? $16,000 $7,000 (restored) $64,000 Center for Devices and Radiological Health What is Quality? (ISO 9000:2000) ability of a set of inherent characteristics of a product, system, or process to fulfill requirements of customers and other interested parties Center for Devices and Radiological Health What is a Customer? (ISO 9000:2000) Customer : organization or person that receives the result of a process Interested party : person or group having an interest in the performance or success of an organization All must be satisfied! Center for Devices and Radiological Health Quality Management System (ISO 9000 definitions) quality management system : s ystem to establish a quality policy and quality objectives and to achieve those objectives Center for Devices and Radiological Health Quality Policy? Center for Devices and Radiological Health Quality Policy?...
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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Lecture 2--Apr 6---Taylor (1) - Center for Devices and...

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