While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
Petite boîte à outils pour réunions difficilesPhilippe Vallat
Petite boîte à outils pour réunions difficiles: de la préparation à la facilitation, en passant par l'engagement des participants et la gestion de l'agressivité.
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
Support de formation, guide, manuel, tutoriel.
Inoreader est un agrégateur de flux RSS qui permet d'indexer et de publier ses flux et d'organiser sa veille sur Internet.
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
Petite boîte à outils pour réunions difficilesPhilippe Vallat
Petite boîte à outils pour réunions difficiles: de la préparation à la facilitation, en passant par l'engagement des participants et la gestion de l'agressivité.
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
Support de formation, guide, manuel, tutoriel.
Inoreader est un agrégateur de flux RSS qui permet d'indexer et de publier ses flux et d'organiser sa veille sur Internet.
2016.09.10 System Center User Group Japan 第15回勉強会のセッション資料です。サンプルコードは GitHub で公開します。
PowerShell DSC の概要(おさらい)と PowerShell DSC for Linux の利用方法、さらに Azure Automation DSC を使用した Aure VM の構成についてお話しました。PowerShell Core for Linux についても簡単にまとめています。
Zabbix
インストール時の注意点
System Center Operations Manager = SCOM
サービスが起動していない
System Center Management Pack for UNIX/Linux
System Center 2016 Management Packs for Open Source Software
System Center Management Pack for Microsoft Azure Stack\
Operations Management Suite = OMS
ソリューションの情報を得るには
OMSとLinux
Linux エージェントのインストール
Linux Syslog
Linux Performance Counter
Apache HTTPD
MySQL
System Center Operations Manager Assessment Configuration
2016.09.10 System Center User Group Japan 第15回勉強会のセッション資料です。サンプルコードは GitHub で公開します。
PowerShell DSC の概要(おさらい)と PowerShell DSC for Linux の利用方法、さらに Azure Automation DSC を使用した Aure VM の構成についてお話しました。PowerShell Core for Linux についても簡単にまとめています。
Zabbix
インストール時の注意点
System Center Operations Manager = SCOM
サービスが起動していない
System Center Management Pack for UNIX/Linux
System Center 2016 Management Packs for Open Source Software
System Center Management Pack for Microsoft Azure Stack\
Operations Management Suite = OMS
ソリューションの情報を得るには
OMSとLinux
Linux エージェントのインストール
Linux Syslog
Linux Performance Counter
Apache HTTPD
MySQL
System Center Operations Manager Assessment Configuration