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third-party inspections because it provides a well-defined plan for conducting facility inspections and could be used to credential third-party inspectors. This HACCP approach is an excellent tool for a manufacturer to use in focusing on the significant areas of the manufacturing and quality system...

...within the industry through the introduction of the latest equipment. Additionally, the examination results are certified as coming from an impartial third party. Tests concerning the colorfastness (the strength of the dye) are conducted based on JIS (Japanese Industrial Standards) for items...

...and devices that are safe and effective with something like an automated pre-shipment screening process or third-party inspection regime and then audit that process off line (after entry), it could use its precious HumINT and inspection resources on demonstrably higher-risk shipments or true unknowns...

...pumps, and, of course, FDA 's long battle with Utah Medical. And, he reveals that despite FDA 's three-year effort to gain industry participation in its third-party inspection program, no firm has yet volunteered. Read his column on page 22 for more details. If you are considering becoming a volunteer...

...such as good manufacturing practices (GMPs), allowing third-party certification instead of requiring direct MHLW approval, and developing a market authorization holder (MAH) system. Today, application forms and certification processes for IVD products differ slightly from other medical devices...

...of notified bodies. However, the United States, Canada, and Japan have begun to increase their use of independent third parties. FDA has used accredited third parties for 510(k) reviews since 1997 and has begun a third- party inspection program. Canada relies entirely upon accredited third parties...

...of first response capabilities will be. the most worthwhile end result. For more information on the full range of ansi-compliant tempered water emergency shower and. eyewash products visit www.hawsco.com. to arrange a free third-party inspection at your facility,. call us at (888) 640-4297. aBoUt...

...the quality audit as a regulatory requirement to ensure compliance, rather than as an opportunity for self-assessment and improvement. These companies often rely on third-party audits to determine compliance with FDA's good manufacturing practices (GMP) regulation, or with the ISO 9000 family...

Achieving third-party certification for your organization's product(s) and/or management. system(s) is an important step in gaining a competitive advantage, while realizing market access. and success. To accomplish this mission, you've completed your homework and have selected. several agencies...

MassMEDIC Honors Innovative Firms. Reexamining Processes Reduces Defects. Third-Party Inspection Program Off to Shaky Start. Medtronic CEO: Medical Technology Is the Path to Increased Healthcare Value. MD &DI Welcomes New Board Member. R &D Digest. Plasma Pencil Could Erase Tumors, Plaque, Bacteria. Tiny...

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