Risk Basics for Medical Devices

Автор: U.S. Food and Drug Administration

Загружено: 2022-11-30

Просмотров: 13604

Описание:

This CDRH Learn module explains U.S. FDA's thoughts on the basics of medical device risk. It provides important definitions, describes basic concepts and lays foundational knowledge on the topic of risk and its use throughout the total product life cycle. To view more educational resources please visit https://www.fda.gov/training-and-cont....

Risk Basics for Medical Devices

Доступные форматы для скачивания:

Скачать видео mp4

Информация по загрузке:

Скачать аудио mp3

Похожие видео

Application of Risk Management Principles for Medical Devices

Application of Risk Management Principles for Medical Devices

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

Is My Product A Medical Device

Is My Product A Medical Device

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

MDUFA IV: Digital Health – A Program Update

MDUFA IV: Digital Health – A Program Update

Medical Device Quality Management System Regulation Risk Management

Medical Device Quality Management System Regulation Risk Management

FDA Direct: Catching Up on Agency Reforms

FDA Direct: Catching Up on Agency Reforms

GCP & Pharmacovigilance Compliance Symposium | D2S06 – Panel Discussion

GCP & Pharmacovigilance Compliance Symposium | D2S06 – Panel Discussion

How is CDRH Structured?

How is CDRH Structured?

Idea to IDE: A Medical Device in the Making

Idea to IDE: A Medical Device in the Making

How is My Medical Device Classified?

How is My Medical Device Classified?

Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy

Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S06 - (PV): Regulatory Updates

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S06 - (PV): Regulatory Updates

Cybersecurity Awareness for Connected Medical Devices

Cybersecurity Awareness for Connected Medical Devices

Medical Device Quality Management System Regulation Design and Development

Medical Device Quality Management System Regulation Design and Development

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

Public Meeting: Reauthorization of the Biosimilar User Fee Act

Public Meeting: Reauthorization of the Biosimilar User Fee Act

GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

Overview of the Quality System Regulation

Overview of the Quality System Regulation

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)