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Case Study: Design Control/Regulatory Response |
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Challenge |
A medium-size manufacturer of invasive therapeutic products was unable to adequately respond to an MDR reportable event which occurred on a vascular device following a change made without sufficient design control. |
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Solution |
AlvaMed created an improved design control system and developed a creative approach to permit the use of the new system on the product in lieu of the company's existing design control system. AlvaMed then led a team composed of a mix of AlvaMed and client personnel which generated the missing design control elements, which ranged from planning and requirements through V&V and design transfer. During this process AlvaMed provided both formal training on design controls and mentoring of client personnel in the proper creation of the various types of DHF documentation needed. |
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Results |
The resulting DHF enabled the company to adequately respond to FDA and the
client members of the team became so well trained in design controls that
they were subsequently assigned to lead other critical development projects.
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More information |
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Bob DiNitto | |
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© 2008 AlvaMed, LLC. All rights reserved. | |||
