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CDRH Learn (New Module - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program)

Fri, 03/23/2012 - 8:31am
U.S. Food & Drug Administration

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion.


Overview of Regulatory Requirements: Medical Devices


Guidance Documents and Standard Operating Procedures (SOPs)

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Norifications or 510(k)s


Premarket Notification Process – 510(k)

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Norifications or 510(k)s

510(k) Overview

Product Codes Making the Connection...

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)

510(k) User Fees

510(k) Third Party Review

"513(g)s".. Including 513(g) User Fees

Post Test for all 510(k) Modules disclaimer icon

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Investigational Device Exemption Process - IDE

What is an Investigational Device Exemption (IDE)?

Idea to IDE: A Medical Device in the Making

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Bioresearch Monitoring (BIMO)

BIMO Part 1a - Good Clinical Practice 101: An Introduction

BIMO Part 1b - Introduction to the Bioresearch Monitoring Program

BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials

BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials

BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations

BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination

BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)

BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use

BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection

BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection

BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection

BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research

BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research

Preparing for a Clinical Investigator Inspection

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Device Establishment Registration and Listing

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CDRH Regulated Software: An Introduction

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Quality System Regulation 21 CFR Part 820

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Medical Device Recalls

Introduction to Medical Device Recalls: Industry Responsibilities

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals

Recall Communication: Medical Device Model Press Release

Recall Communication: Medical Device Model Recall Notification Letter

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Medical Device Reporting (MDR)

MAUDE - Information Available to the Public

Electronic Medical Device Reporting (eMDR)

Medical Device Reporting

MDR for User Facilities

MDR for Manufacturers and Importers

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Export Certificates for Medical Devices

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Regulation of Radiation-Emitting Products

How to Get Your Electronic Product on the U.S. Market

Phantom Image Scoring (For MQSA Inspectors)

eSubmitter Tutorial Videos

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ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

Single Audit Program - Quality Management System Audit Reports (GD211)

GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma

GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma (French audio-only)

GD211 - Module 1 - Introduction

GD211 - Module 1 - Introduction (French audio-only)

GD211 - Module 2 - Information about the Manufacturer

GD211 - Module 2 - Information about the Manufacturer (French audio-only)

GD211 - Module 3 - Information about the Audit

GD211 - Module 3 - Information about the Audit (French audio-only)

GD211 - Module 4 - Audit Findings

GD211 - Module 4 - Audit Findings (French audio-only)

GD211 - Module 5 - Conclusions

GD211 - Module 5 - Conclusions (French audio-only)

TEST LINK: GD211 Training Course (English) disclaimer icon

TEST LINK: GD211 Training Course (French Canadian) disclaimer icon

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FDA's Home Use Medical Device Initiative

Promoting Patient Safety with Home Use Devices

Home Use Medical Devices: New Risks

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  • Advanced Quality Systems: Corrective and Preventive Actions
  • Imports
  • Premarket Approvals
  • Home Healthcare

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