Regulatory Documents Explained - DHF, DMR, DHR and TF

Автор: GlobalCompliance Panel

Загружено: 2016-07-13

Просмотров: 6136

Описание: The FDA QSR and the Medical Device Directive specify certain records that should be included in your organization's quality system - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical File (TF).

For More Information Contact -

Organization: NetZealous BDA GlobalCompliancePanel
Website: http://www.globalcompliancepanel.com/
Email: [email protected]

Help us caption & translate this video!

http://amara.org/v/Q7i1/

Не удается загрузить Youtube-плеер. Проверьте блокировку Youtube в вашей сети.
Повторяем попытку...

Regulatory Documents Explained - DHF, DMR, DHR and TF

Доступные форматы для скачивания:

Скачать видео

Информация по загрузке:

Скачать аудио

Похожие видео

FDA Quality Systems Regulation Requirements - Regulatory Documents Explained

FDA Quality Systems Regulation Requirements - Regulatory Documents Explained

Documentation Deconstructed: Understanding the Technical file

Documentation Deconstructed: Understanding the Technical file

Design Controls - Requirements for Medical Device Developers

Design Controls - Requirements for Medical Device Developers

Контроль проектирования медицинских изделий — вводный онлайн-курс

Контроль проектирования медицинских изделий — вводный онлайн-курс

How to you create a Design History File (DHF)?

How to you create a Design History File (DHF)?

How to estimate risk for a medical device according to ISO 14971:2019

How to estimate risk for a medical device according to ISO 14971:2019

Medical Device Design Control

Medical Device Design Control

How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements

How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements

Supplier and Internal Auditing

Supplier and Internal Auditing

Medical Devices Regulation Training

Medical Devices Regulation Training

Complaint Handling in Compliance with FDA and ISO Regulations

Complaint Handling in Compliance with FDA and ISO Regulations

Process Validation Procedure for Medical Device Manufacturers

Process Validation Procedure for Medical Device Manufacturers

Nobody Complained! Post market reporting under MDR

Nobody Complained! Post market reporting under MDR

Protocols for Medical Devices & Process Validation Principles

Protocols for Medical Devices & Process Validation Principles

Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Developing a Testing Plan for Medical Device Design Verification

Developing a Testing Plan for Medical Device Design Verification

Webinar | SAP S/4HANA for Cloud ERP Transformation | SARACA

Webinar | SAP S/4HANA for Cloud ERP Transformation | SARACA

Medical Devices - ISO 14971 : Risk Management

Medical Devices - ISO 14971 : Risk Management

FDA 101 for Medical Devices

FDA 101 for Medical Devices

Recording of Usability Process Webinar

Recording of Usability Process Webinar