Abstract: . . .  include: specifications for raw materials, component parts and sub-assemblies, drawings and parts list, customer training materials, process and materials specifications, finished medical devices, product and process software, quality assurance procedures (including acceptance criteria), manufacturing and inspection procedures, Slide 110 of 57 Risk Management Principles within a Quality Management System (Santiago, Chile, May 2006) Gunter Frey GHTF SG3 7. Product Realization 7.3 Design and development Design outputs (cont): work environment requirements needed for the device, packaging and labeling specifications, identification and traceability requirements (including procedures, if necessary), installation and servicing procedures and materials, . . .
. . .  for raw materials, component parts and sub-assemblies, drawings and parts list, customer training materials, process and materials specifications, finished medical devices, product and process software, quality assurance procedures (including acceptance criteria), manufacturing and inspection procedures, Slide 110 of 57 Risk Management Principles within a Quality Management System (Santiago, Chile, May 2006) Gunter Frey GHTF SG3 7. Product Realization 7.3 Design and development Design outputs (cont): work environment requirements needed for the device, packaging and labeling specifications, identification and traceability requirements (including procedures, if necessary), installation and servicing procedures and materials, documentation for submission . . .
. . .  requirements with respect to the environment of intended use, packaging and labeling (including considerations to deter foreseeable misuse), customer/user training requirements, regulatory and statutory requirements of intended markets, relevant voluntary standards (including industry standards, national, regional or international standards, “harmonized” and other consensus standards), Slide 106 of 57 Risk Management Principles within a Quality Management System (Santiago, Chile, May 2006) Gunter Frey GHTF SG3 7. Product Realization 7.3 Design and development Design inputs (cont.): manufacturing processes, sterility requirements, economic and cost aspects, lifetime of the medical device requirements, and need for servicing. Slide 107 of 57 Risk . . .
. . .  this writing E-Mail: jisc@meti.go.jp Web Site: http://www.jisc.go.jp/eng/ Sources of Standards - JISC Quality Management Systems: History and Evolution Presented by Jan Welch U.S. Food and Drug Administration Center for Devices and Radiological Health Slide 59 of 57 Risk Management Principles within a Quality Management System (Santiago, Chile, May 2006) Gunter Frey GHTF SG3 Introduction Why comply with quality management system standard What is a quality management system ? Evolution of quality practices Slide 60 of 57 Risk Management Principles within a Quality Management System (Santiago, Chile, May 2006) Gunter Frey GHTF SG3 Why should a manufacturer comply with a quality management system standard? Provides high degree of assurance that manufacturer . . .
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