Regulatory Open Forum

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  • 1.  Design Verification Plan and Protocol

    Posted 03-Apr-2019 09:35
    ​Hi All,

       Can any one give me some insights on Medical Electronic Device(Implant) design verification plan and protocol. Any templates or books to be referred would also help me. What are the general requirements for safety, performance, marking and packaging to be considered.





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    Jayaram Abimanyu
    Chennai
    India
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  • 2.  RE: Design Verification Plan and Protocol

    Posted 03-Apr-2019 14:57
    ​Hello Jayaram.  Please refer to my response to your other similar question here.

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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
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