HOW TO FIND AND EFFECTIVELY USE PREDICATE DEVICES
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
Length: 00:30
FDA IVD REGULATION
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
Welcome to the Meditrial training on FDA IVD Regulation. In this training, you will learn what an IVDs are and the factors needed for regulation and classification.
Length: 00:20
FDA EARLY FEASIBILITY STUDY PROGRAM
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
Welcome to the Meditrial training on FDA Early Feasibility Study Program. In this training, you will learn what an Early Feasibility Study is and when is needed.
We will provide insights concerning Early Feasibility Studies and FDA applicable requirements. We will guide you through the steps needed for a successful EFS submission despite challenges that may impact the process. Moreover, you will get recommendations on the submission process and helpful information.
We will provide insights concerning Early Feasibility Studies and FDA applicable requirements. We will guide you through the steps needed for a successful EFS submission despite challenges that may impact the process. Moreover, you will get recommendations on the submission process and helpful information.
Length: 00:20
510(k) Submission Process
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 69 USD
This 510(k) Submission Video Course is designed to help you discover the 510(k) submission process and provide you with an overview on the submission review process, and applicable timelines.
Length: 00:30
FDA Q-Submission Process
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 89 USD
This Q-Submission Process Video Course is designed to help you discover the Q-submission process and provide you with an overview on the submission review process, and applicable timelines.
Length: 00:45
Breakthrough Device Designation
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
This Breakdown Device Designation Video Course is designed to help you discover the Breakthrough Device Designation Program and how to request for the designation of a device in the Breakthrough Program.
Length: 00:10
Emergency Use Authorization (EUA)
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
The Emergency Use Authorization Video Course is designed to help you discover the Emergency Use Authorization and how to apply through this pathway in the U.S.
Length: 00:15
De Novo Classification Pathway
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
This Meditrial Video Course is designed to help you discover the FDA De Novo Classification Pathway and intended to provide De Novo requesters with transparency regarding the process of submission De Novo Classification request.
Length: 00:45
FDA Clinical Laboratory Improvement Amendments (CLIA)
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
The Clinical Laboratory Improvement Amendments Video Course is designed to help you discover the CLIA and how to determine and apply for CLIA waiver or Dual 510(k) by application studies.
Length: 00:30
FDA Safer technology program (STeP)
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
The Safer Technology Program Video Course is designed to help you discover STeP and how to navigate program principles and structure. You will also learn about the factors for the STeP entrance and review process.
Length: 00:20
FDA Premarket Approval (PMA)
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 79 USD
In the Premarket Approval course we will provide regulatory information on the Premarket Approval process.
Length: 00:50
FDA Medical Device Development Tools (MDDT) Program
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the Medical
Device Development Tools Program, this program is a way for the FDA to qualify tools that medical device sponsors can use in the
development and evaluation of medical devices.
Length: 00:20
Monitoring for Medical Devices in the US Essential FDA Guidelines
FDA Medical Device Regulation for EveryoneDuration: Unlimited
Cost: 49 USD
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the monitoring essential guidelines for medical devices in the US. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.
Length: 00:10