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日本代购-欧州医療機器規則(MDR)/欧州体外診断用医療機器規則(IVDR)の最新情報及び臨床評価のポイント
  • ecompliance:10000783
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日本代购-講師 株式会社イーコンプライアンス 代表取締役 村山 浩一 総収録時間 262分 納品方法 セミナー映像・資料はDVDで納品いたします。 出版社 株式会社イーコンプレス 出版年月日 2024年9月24日 内容情報 ■講座のポイント   欧州市場への医療機器進出を目指すなら、MDR/IVDRへの対応は避けて通れません。  本セミナーでは、欧州医療機器規則(MDR)および欧州体外診断用医療機器規則(IVDR)の最新情報と、それらに関する臨床評価および性能評価の重要なポイントを解説します。初心者でも理解しやすいよう、規則の基本から具体的な実施方法までを丁寧に説明します。また、実際の事例を交えながら、実務に役立つ情報を提供します。  本セミナーを通じて、参加者は最新の規則に基づく適切な臨床評価および性能評価を行うための知識とスキルを習得できます。  具体例を交えながら、臨床評価計画の作成、臨床データ収集、文献レビュー、PMSとの連携など、実務に直結する内容を分かりやすくお伝えします。経験豊富な専門家が、貴社の欧州市場進出を強力にサポートします。 ■受講後、習得できること ・MDR/IVDRの全体像と最新情報、改正ポイント ・臨床評価・性能評価の重要性と具体的な実施方法 ・臨床評価計画の作成、臨床データ収集、文献レビューの方法 ・MDRおよびIVDRの最新動向とそれに伴う変更点の把握 ■本テーマ関連法規・ガイドラインなど ・欧州医療機器規則 (MDR: Medical Device Regulation (EU) 2017/745) ・欧州体外診断用医療機器規則 (IVDR: In Vitro Diagnostic Medical Device Regulation (EU) 2017/746) ・MEDDEV 2.7/1 rev. 4 (臨床評価に関するガイダンス) ・MDCG(Medical Device Coordination Group)ガイダンス (MDR/IVDR関連ガイダンス) ■講演中のキーワード ・MDR ・IVDR ・臨床評価 ・適合性評価 ・CEマーキング 1.はじめに 2.MDR概要 3.IVDR概要 4.MDR/IVDRに関する最新の動向 5.臨床評価概要 6.性能評価概要 7.PMS/ビジランス概要 注意事項 納品後のキャンセルはお受けできませんので予めご了承ください。 ※本DVDに含まれる教材を視聴するためには、DVDドライブを装備したPCが必要です。イーコンプレスVOD配信セミナー セミナー映像・資料はDVDで納品 自主学習・企業内でのグループ研修におすすめ 新人社員研修などに最適 地方や自宅(テレワーク)でも受講できる
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页面Trace信息
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请求方法 : GET
通信协议 : HTTP/1.1
请求时间 : 2025-07-19 09:46:15
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输出编码 :
加载类库 : 36
模板编译 : 重新编译
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[ 25-07-19 09:46:16 ] RunTime:0.001000s SQL = SHOW COLUMNS FROM bio_agent
[ 25-07-19 09:46:16 ] RunTime:0.000271s SQL = SELECT * FROM bio_agent WHERE ( `isViews` = 1 ) AND ( `domain` LIKE '%test.ripai.com' )
[ 25-07-19 09:46:16 ] RunTime:0.000209s SQL = SELECT * FROM bio_agent WHERE ( `domain` = 'www.jp-daigou.com' )
[ 25-07-19 09:46:16 ] RunTime:0.000341s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
[ 25-07-19 09:46:16 ] RunTime:0.000346s SQL = SHOW COLUMNS FROM bio_point
[ 25-07-19 09:46:16 ] RunTime:0.001147s SQL = SHOW COLUMNS FROM bio_user
[ 25-07-19 09:46:16 ] RunTime:0.000900s SQL = SELECT * FROM bio_goods WHERE `isView` = 1 and gType<=3 ORDER BY created DESC LIMIT 15
[ 25-07-19 09:46:16 ] RunTime:0.000944s SQL = SHOW COLUMNS FROM bio_syscolumn
[ 25-07-19 09:46:16 ] RunTime:0.000357s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = 17 ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-19 09:46:16 ] RunTime:0.000335s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '19' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
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[ 25-07-19 09:46:16 ] RunTime:0.000649s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '20' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
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[ 25-07-19 09:46:17 ] RunTime:0.000184s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=500182
[ 25-07-19 09:46:17 ] RunTime:0.000162s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101354
[ 25-07-19 09:46:17 ] RunTime:0.000154s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101240
[ 25-07-19 09:46:17 ] RunTime:0.000147s SQL = SELECT * FROM bio_rakutencategory WHERE parentid=101379
[ 25-07-19 09:46:17 ] RunTime:0.000313s SQL = SHOW COLUMNS FROM bio_rate
[ 25-07-19 09:46:17 ] RunTime:0.000166s SQL = SELECT * FROM bio_rate WHERE ( `type` = 'RMB->JPY' ) ORDER BY date desc LIMIT 1
错误记录 : 101条错误
[ 25-07-19 09:46:16 ] 注意:[8] A session had already been started - ignoring session_start() App.class.php 第 115 行.
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[ 25-07-19 09:46:16 ] 注意:[2048] Redefining already defined constructor for class Net_URL URL.php 第 122 行.
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[ 25-07-19 09:46:16 ] 注意:[2048] Redefining already defined constructor for class XML_Parser Parser.php 第 206 行.
[ 25-07-19 09:46:16 ] 注意:[8192] Assigning the return value of new by reference is deprecated Parser.php 第 576 行.
[ 25-07-19 09:46:16 ] 注意:[2048] Declaration of XML_Parser::raiseError() should be compatible with that of PEAR::raiseError() Parser.php 第 634 行.
[ 25-07-19 09:46:16 ] 注意:[8] Undefined index: openid BaseAction.class.php 第 72 行.
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[ 25-07-19 09:46:16 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
[ 25-07-19 09:46:16 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 228 行.
[ 25-07-19 09:46:16 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-19 09:46:16 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
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[ 25-07-19 09:46:17 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-07-19 09:46:17 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
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[ 25-07-19 09:46:17 ] 注意:[8] Undefined variable: options Unserializer.php 第 448 行.
[ 25-07-19 09:46:17 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
[ 25-07-19 09:46:17 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 509 行.
[ 25-07-19 09:46:17 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context RakutenAction.class.php 第 595 行.
[ 25-07-19 09:46:17 ] 注意:[8] Undefined index: isDebugMe RakutenAction.class.php 第 607 行.
[ 25-07-19 09:46:17 ] 注意:[8] Undefined index: categoryPath RakutenCategoryGetter.class.php 第 55 行.
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[ 25-07-19 09:46:17 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
[ 25-07-19 09:46:17 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-19 09:46:17 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
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[ 25-07-19 09:46:17 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-19 09:46:17 ] 注意:[8] Undefined offset: 0 ThinkTemplate.class.php 第 578 行.
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