Канал: Invent Healthcare

Factors for Benefit Risk Determination in Medical Device Premarket Approval De Novo Classification

Factors for Benefit Risk Determination in Medical Device Premarket Approval De Novo Classification

Webinar: Digital Health Approach by FDA

Webinar: Digital Health Approach by FDA

Webinar: Medical Devices in the Home: Design Considerations and FDA Guidance

Webinar: Medical Devices in the Home: Design Considerations and FDA Guidance

Regulatory Overview for Developers & Sponsors of Neurological Devices Premarket PMA Approval Part 2

Regulatory Overview for Developers & Sponsors of Neurological Devices Premarket PMA Approval Part 2

Regulatory Overview for Developer & Sponsor of Neurological Device to Starting Human Studies Part 1

Regulatory Overview for Developer & Sponsor of Neurological Device to Starting Human Studies Part 1

Webinar: Medical Devices Cybersecurity in 510(k) Premarket Submissions

Webinar: Medical Devices Cybersecurity in 510(k) Premarket Submissions

Webinar: What is CDRH Regulated Software: An Introduction

Webinar: What is CDRH Regulated Software: An Introduction

Webinar: Self Monitoring Glucose System for Over-the-Counter OTC Use and Point of Care Use

Webinar: Self Monitoring Glucose System for Over-the-Counter OTC Use and Point of Care Use

Webinar: Introduction to Good Clinical Practice (GCP) for Clinical Trials

Webinar: Introduction to Good Clinical Practice (GCP) for Clinical Trials

Case Study: FDA Regulatory Responsibilities for Color Additives 510(k) Premarket Notification

Case Study: FDA Regulatory Responsibilities for Color Additives 510(k) Premarket Notification

Case Study: FDA Regulatory Responsibilities for Medical Gown 510(k) Premarket Notification

Case Study: FDA Regulatory Responsibilities for Medical Gown 510(k) Premarket Notification

Introduction to FDA Office of Orphan Product Development and Rare Diseases

Introduction to FDA Office of Orphan Product Development and Rare Diseases

US FDA Resources for Standards Program and Standards Development Organization (SDO)

US FDA Resources for Standards Program and Standards Development Organization (SDO)

US FDA Standards Overview

US FDA Standards Overview

CDRH Standards Recognition Process

CDRH Standards Recognition Process

Webinar: Principles for Co-development of In-Vitro Companion Diagnostic Device w Therapeutic Product

Webinar: Principles for Co-development of In-Vitro Companion Diagnostic Device w Therapeutic Product

US FDA Medical Device Home Use Initiative

US FDA Medical Device Home Use Initiative

Webinar: Applying Human Factors and Usability Engineering to Medical Devices

Webinar: Applying Human Factors and Usability Engineering to Medical Devices

Digital Health Software Precertification (PreCert) Pilot Program

Digital Health Software Precertification (PreCert) Pilot Program

General Wellness Policy for Low Risk Devices

General Wellness Policy for Low Risk Devices

Webinar: Introduction to FDA Unique Device Identification (UDI) Requirements Part II

Webinar: Introduction to FDA Unique Device Identification (UDI) Requirements Part II

Webinar: Premarket Approval Application for Automated External Defibrillator (AED) Overview

Webinar: Premarket Approval Application for Automated External Defibrillator (AED) Overview

Webinar: Promoting Patient Safety with Home Use Devices

Webinar: Promoting Patient Safety with Home Use Devices

Webinar: Custom Device Exemption Overview

Webinar: Custom Device Exemption Overview

Webinar: Management of Cybersecurity for Medical Devices after Approval

Webinar: Management of Cybersecurity for Medical Devices after Approval

Webinar: Introduction to FDA Home Use Medical Device Initiative

Webinar: Introduction to FDA Home Use Medical Device Initiative

Webinar: Sterility Information in Premarket Notification (510k) Submissions for Medical Device

Webinar: Sterility Information in Premarket Notification (510k) Submissions for Medical Device

Webinar: FDA Unique Device Identification (UDI) Requirements

Webinar: FDA Unique Device Identification (UDI) Requirements

Webinar: Purchasing Controls and Process Validation for Supply Chain Management

Webinar: Purchasing Controls and Process Validation for Supply Chain Management

Webinar: Quality System Management Controls and Design Controls

Webinar: Quality System Management Controls and Design Controls

Webinar: Introduction to US FDA Medical Device Regulations (510k, De Novo, IDE, CAPA, eMDR)

Webinar: Introduction to US FDA Medical Device Regulations (510k, De Novo, IDE, CAPA, eMDR)

Webinar: FDA GUDID Health Level 7 (HL7) Structured Product Labeling (SPL) Submission

Webinar: FDA GUDID Health Level 7 (HL7) Structured Product Labeling (SPL) Submission

Webinar: Submission of Cybersecurity Information in Premarket Notification (510k)

Webinar: Submission of Cybersecurity Information in Premarket Notification (510k)

FDA 510K Premarket Notification Webinar

FDA 510K Premarket Notification Webinar

Lecture 24: Generalized Linear Models Part 4 (MIT 18.650)

Lecture 24: Generalized Linear Models Part 4 (MIT 18.650)

Lecture 23: Generalized Linear Models Part 3 (MIT 18.650)

Lecture 23: Generalized Linear Models Part 3 (MIT 18.650)

Lecture 22: Generalized Linear Models Part 2 (MIT 18.650)

Lecture 22: Generalized Linear Models Part 2 (MIT 18.650)

Lecture 21: Generalized Linear Models Part 1 (MIT 18.650)

Lecture 21: Generalized Linear Models Part 1 (MIT 18.650)

Lecture 20: Principal Component Analysis Part 2 (MIT 18.650)

Lecture 20: Principal Component Analysis Part 2 (MIT 18.650)

Lecture 19: Principal Component Analysis Part 1 (MIT 18.650)

Lecture 19: Principal Component Analysis Part 1 (MIT 18.650)

Lecture 18: Bayesian Statistics Part 2 (MIT 18.650)

Lecture 18: Bayesian Statistics Part 2 (MIT 18.650)

Lecture 17: Bayesian Statistics Part 1 (MIT 18.650)

Lecture 17: Bayesian Statistics Part 1 (MIT 18.650)

Lecture 15: Regression Part 3 (MIT 18.650)

Lecture 15: Regression Part 3 (MIT 18.650)

Lecture 14: Regression Part 2 (MIT 18.650)

Lecture 14: Regression Part 2 (MIT 18.650)

Lecture 13: Regression Part 1 (MIT 18.650)

Lecture 13: Regression Part 1 (MIT 18.650)

Lecture 12: Testing Goodness of Fit Part 2 (MIT 18.650 )

Lecture 12: Testing Goodness of Fit Part 2 (MIT 18.650 )

Lecture 11: Parametric Hypothesis Testing and Testing Goodness of Fit (MIT 18.650)

Lecture 11: Parametric Hypothesis Testing and Testing Goodness of Fit (MIT 18.650)

Lecture 9: Parametric Hypothesis Testing Part 3 (MIT 18.650)

Lecture 9: Parametric Hypothesis Testing Part 3 (MIT 18.650)

MIT 18.650 Lecture 8: Parametric Hypothesis Testing Part 2

MIT 18.650 Lecture 8: Parametric Hypothesis Testing Part 2

Lecture 7: Parametric Hypothesis Testing (MIT 18.650)

Lecture 7: Parametric Hypothesis Testing (MIT 18.650)

Lecture 6: Maximum Likelihood Estimation and the Method of Moments (MIT 18.650)

Lecture 6: Maximum Likelihood Estimation and the Method of Moments (MIT 18.650)

Lecture 5: Maximum Likelihood Estimation (MIT 18.650)

Lecture 5: Maximum Likelihood Estimation (MIT 18.650)

Lecture 4: Parametric Inference (cont.) and Maximum Likelihood Estimation (MIT 18.650)

Lecture 4: Parametric Inference (cont.) and Maximum Likelihood Estimation (MIT 18.650)

Lecture 3: Parametric Inference (MIT 18.650)

Lecture 3: Parametric Inference (MIT 18.650)

Lecture 2: Introduction to Statistics (MIT 18.650)

Lecture 2: Introduction to Statistics (MIT 18.650)

Webinar: Design Considerations for FDA Medical Device Home Use

Webinar: Design Considerations for FDA Medical Device Home Use

Webinar: Introduction to US Food and Drug Administration (FDA 101)

Webinar: Introduction to US Food and Drug Administration (FDA 101)