Shanghai event resources: Medical Device Regulations and Technology Forum
We hope you enjoyed our event on 16 / 17 May 2013 'Medical Device Regulations and Technology Forum' and that you found the two day forum useful and informative.
All presentations from the day are available to download as a pdf below.
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EU state of play and the changing global regulatory environment - BSI Gert Bos (1MB) >
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Case study CE Marking Application - Lepu Daiyan (2MB) >
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FDA QSIT Inspection - Scott Yu (1MB) >
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ISO 13485 3rd edition - BSI Vicky Medley (1MB) >
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Canadian Regulation - BSI Stewart Brain (980KB) >
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Japan Regulation - BSI Seiko Oyama (1MB) >
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Taiwan Regulation - BSI Hailey Chu (916KB) >
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Overview of EU TF requirements & Main findings - BSI Liang Qian (925KB) >
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Clinical Evaluation - BSI Gert Bos (1MB) >
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PMS NB Perspective - BSI Liang Qian (890KB) >
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PMS Regulatory requirements and practice in China - S&N Alex Jiang (1MB) >
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EN ISO 14971 2012 and its influences on Quality & Technical File audits - BSI Vicky Medley (1MB) >
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AIMD & Software - BSI Lee Glanzmann (1MB) >
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MD Software Registration - Nihon Kohden AoHaiDong (1MB) >
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Sterilization NB Perspective - BSI Stewart Brain (993KB) >
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EB Validation requirements for Sterilization process VS practices - Sterigenics Grace Lu (852KB) >
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EtO Sterilization - Sterigenics Seagle Xu (520KB) >
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Device Drug Combinations & Animal Tissue Products - BSI Gert Bos (1MB) >
