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21 CFR Part 11. FDA CFR 820 QSR対応. 当社コンサルテーションへのご要望 ご質問 お問合せは こちら. 本邦において、2017年11月より、IEC 62304 医療機器ソフトウェア ソフトウェアライフサイクルプロセス が、実質的な規制要件となりました。 IEC 62304は、2006年5月に発行され、日本では2012年にJIS化 JIS T 2304 されました。 IEC 62304は 医療機器ソフトウェア の開発と保守に関するプロセスを規定しています。 日本以外でも、欧州 北米 中国などにおいて、医療機器申請時にIEC 62304に基づくソフトウェア開発の証拠が必要です。 つまり、IEC 62304に従って、 医療機器ソフトウェア を開発しなければ、国内外においてソフトウェアを搭載した医療機器 単体プログラムを含む を販売することができません。 本 IEC 62304対応規程 手順書ひな形 を導入いただくことによってIEC 62304に準拠したQMSを効率的 効果的に作成することができます。 入門編 データインテグリティ編 FDA査察対応セミナー2日間コース ライブ配信対応.
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eCompliance EHS Management Software for Compliance & Reporting
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eCompliance: Acerca de Business Compliance Group
Impulsando el alto desempeño. Acerca de Business Compliance Group. Business Compliance Group, SAPI de C.V. Es la principal accionista de empresas dedicadas a implementar soluciones autoregulatorias dentro de las organizaciones tanto públicas como privadas, mediante la integración de productos y servicios:. Compliance Officers, S.C.,. A través de este concepto generamos los mecanismos necesarios que fomentar el cumplimiento normativo tanto interno y externo de nuestros clientes. Es una empresa que s.
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eCompliance Homepage
ECompliance, Inc. uses advanced technologies to streamline the compliance process for government agencies, universities and businesses. The eCompliance.net framework supports a variety of tools and services that promote efficient communication and data transactions, including industry-specific electronic regulatory exchanges and collaborative enterprise applications. The company enables legally binding electronic compliance transactions through eCompliance.net, a framework that combin...
RMP Program - eCompliance
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Mosaic Compliance Services | Making virtue profitable | Home
Ensp;Add to your calendar . ICalendar / Outlook Calendar. The event can't be recovered after its deletion. Proceed anyway? I forgot my password. Practical, Effective, Affordable Compliance Training. Having trouble logging in? All passwords were reset to changeme. When the upgrade occurred. Once you login for the first time, you will be able to change your password. All user names have been reformatted to all caps for consistency. Let us know what you think. We value your feedback!
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