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------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/pres.xml Content-Transfer-Encoding: quoted-printable Content-Type: text/xml; charset="utf-8" ------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/slide0001.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" How Medical Device Firms Are Conducting Management Reviews
How Medical Device Firms Ar= e Conducting Management Reviews
Nancy Singer, Compliance-Alliance
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Compliance-Alliance Sent Ou= t a Survey
•301 firms fille= d it out
<= span class=3DBB style=3D'position:absolute;left:-3.93%'>•Response rate w= as higher than other surveys
•90 individuals expressed interest in doing further benchmarking work
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Classes of Devices Represented
* Firms manufactured more than 1 class of devices
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Is the Review Important an= d Is It on the Company’s Radar Screen?
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Do employees understand that se= nior management conducts management reviews?
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How do people learn about
the reviews?
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Does your firm conduct reviews by holding a formal meeting?
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Who Attends the Reviews?
------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/slide0009.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" How Medical Device Firms Are Conducting Management Reviews
What function within your firm serves as the management representative?
------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/slide0009_image005.emz Content-Transfer-Encoding: base64 Content-Type: image/x-emz H4sIAAAAAAACC91ZXWhcRRQ+9+7Wbbdrk91sqNVWo7FNHoRsojEqrWmsjShG07gtpRRtq9VEkrQQ cAUj3bRVCpHiiz/RBkKrxp9qLUXwoQ8KShTykAeFPhURFME8NKgPgrB+Z+6Z3dnJ7r0rWrfNhS/z 8935zjlzZu7cvXGIaBBIADXAkEv0mkP563gH0Qu3ETVs7ekmcmjqeqJh8Muo+JpCx9EQ0WZwlyyO fgxT9oMQQYAaxFbPYw/00fItDzoUJhe6zRh3HfpjMmSN1HO5HCWlfq2M5TrcpJuB5cAthXtzpfqi KGsNd/Q9pg3Tdh9w0OFoiX5h0rjOu/lqIk0DNET7aQRRPYIyg7KPDqBvLw1T5dceQQP9lbtJzRCt 5j8X3kxQ/OVwqv/tBJ1AnU0/9ZxyXc3/F+j78KWFzB6gIfVHhihKtWc6acfwQiYDLESjdQweXz/1 Sur8yBQprbcSFD4cTiFrNIs6W0zPJhTYxtGJhPLrVnAv8hxIeQnlRnCxxrFR756x0c0dx0ZfbUlS L9p/nvsuc/yamHcv5u3dQwuZn48oP5K70TeLe+6HD5+iHDoUTulY1svcO2XqyHu2VI7Ne8vl8kby 1pW+sgjwI+fq0Q4LRqE9/R9rnwBWAY9D+9nLoM19T0B7AAN4768Ve97ev69Xz9sG4fTWMh4/eZvM NYl2SLgc5YruCVHhGcJ+5X2k8s+QHQA2Ak0CrTB8CuUueb5NoueUwi5nUqHV4TiSMh9eHFt7S8fm qDhM/XngNFCf159Hm1EPbcY8Va7vLvJ/GvgKmCOtP402Yw71OdWuXD+k5rPJWIeyyovmnPubjflf k18L2SLf9vH5AofH877tQ5sxjvq4alfuW1jZNfXXcV5db515+uvQZnSj3q3apfR1HBE4vL6wjrP/ ZC+Yc2GuV3MuzHUZtP+q4Yv9DNN7MuSzJ0NG7tnGDXLOcj76neAznDXvlDG7XW+MqXHAKfBaU/Nt TjHPbZOfsfgZi2d7Jl/Kfg2Vt/+6tP34RotvtPiLlv5FKuYnLH7C4tMWn7Z42/8aunxrLFTmTPBb Y+XOfb+zopr+v8PPGwh8LmeEee6VW99pwfvA3eg4x++X8m65duZs1/bt33dpjvsett4Nc3LxBLRR kxMrE8v/NR9+7z1+z9fKcuxUPaaPgV+BL+WcDsrrWeB3/l3A91h51VxQXttFd+nm1XtXqWZMXwPv AT/J+5FfXncC3wJngB+Ab6g4r5pzA/LaSrcr3aWdW+89sZox1SKWvSg3yvulX275d3aS37dQdqA8 YuVWcyGf3KZVbtvoDtFe+jkOF/lQjZjqXM+vTrcQj1+OV7ue/j0o77VyrLlKcty+BHJcDf/0PI7B v9MVnKNv8DcOdJwk7/ujmS/NBZ2jKdHVz/ANjjduk7NYU3Nu4Nmcyuder63PZOyFErqaC15bqby/ tv5Drqehv8Wa+poL1m9fpH8lrderZW0OyvfguxzvbNlm5UNzy3zysVNx++kZnFKD8ntspZGXiNg6 JvZ/I89WzLKluaiPLV4/W9Q36IOwNaC+RD8J23GxVSdxRgQ67pUC9uN59VuD6BPxY8Z6fmou4uMH f+/toacRcws9Cl9G5KN2xIhZ+7LC2LP9wIDYPWzZ1VzQnt1GXUo7buSwk79ni+4mS1dzQTlk3Ras hi7xPS5xxAVX4v6CTra5hGbE6A9Z/y9ZIWtUawX9v+Tf/K/FHLtKzjASDa7/DYLrnZagGgAA ------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/slide0011.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" How Medical Device Firms Are Conducting Management Reviews
How often does the manageme= nt representative attend the review?
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How often does the presid= ent attend the review?
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How often do board members = attend the review?
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How often do senior executives attend the review?
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How often do managers att= end the review?
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What functions regularly at= tend the review?
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How often does the legal function attend the review?
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To have a review, what functions besides the management rep. need to be present?
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How are Management Reviews= Organized?
------=_NextPart_01C81252.0CE0B390 Content-Location: file:///C:/51962353/ManagemenReviews_files/slide0007.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" How Medical Device Firms Are Conducting Management Reviews