01:21:42

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

01:14:43

Webinar: Digital Health Approach by FDA

41:06

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

01:02:48

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

01:12:01

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

01:22:14

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

38:33

Webinar: What is CDRH Regulated Software: An Introduction

01:02:37

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

28:39

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

01:22:49

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

01:02:33

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

18:32

Introduction to FDA Office of Orphan Product Development and Rare Diseases

14:26

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

22:18

US FDA Standards Overview

09:27

CDRH Standards Recognition Process

01:07:27

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

23:50

US FDA Medical Device Home Use Initiative

01:27:09

Webinar: Applying Human Factors and Usability Engineering to Medical Devices

01:10:37

Digital Health Software Precertification (PreCert) Pilot Program

58:11

General Wellness Policy for Low Risk Devices

02:00:07

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

28:51

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

22:00

Webinar: Promoting Patient Safety with Home Use Devices

47:04

Webinar: Custom Device Exemption Overview

01:27:06

Webinar: Management of Cybersecurity for Medical Devices after Approval

12:33

Webinar: Introduction to FDA Home Use Medical Device Initiative

52:43

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

01:56:59

Webinar: FDA Unique Device Identification (UDI) Requirements

02:00:41

Webinar: Purchasing Controls and Process Validation for Supply Chain Management

02:02:38

Webinar: Quality System Management Controls and Design Controls

04:58:23

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

40:36

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

01:22:12

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

55:20

FDA 510K Premarket Notification Webinar

54:45

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

01:18:21

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

01:17:20

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

01:15:14

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

01:16:54

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

01:17:12

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

01:03:06

Lecture 18: Bayesian Statistics Part 2 (MIT 18.650)

01:18:05

Lecture 17: Bayesian Statistics Part 1 (MIT 18.650)

01:15:29

Lecture 15: Regression Part 3 (MIT 18.650)

01:13:59

Lecture 14: Regression Part 2 (MIT 18.650)

01:16:02

Lecture 13: Regression Part 1 (MIT 18.650)

01:21:17

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

01:22:48

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

01:21:22

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

01:18:33

MIT 18.650 Lecture 8: Parametric Hypothesis Testing Part 2

01:18:51

Lecture 7: Parametric Hypothesis Testing (MIT 18.650)

01:19:09

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

01:16:32

Lecture 5: Maximum Likelihood Estimation (MIT 18.650)

01:17:57

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

01:22:37

Lecture 3: Parametric Inference (MIT 18.650)

01:17:09

Lecture 2: Introduction to Statistics (MIT 18.650)

41:06

Webinar: Design Considerations for FDA Medical Device Home Use

52:02

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