United States
Courses tagged with "United States"
Clinical Trial Information System (CTIS)
Clinical TrialsDuration: Unlimited
Cost: 99 USD
In this course, you will learn all the important information about the CTIS, its timelines and user roles. You’ll also discover what training materials are available at European Medicines Agency website.
Category: Clinical Trials
Length: 00:20
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
Clinical Trials in USDuration: Unlimited
Cost: 79 USD
Welcome to the Investigational Device Exemption or IDE training. In this training, you will learn what IDE means, and how to prepare and submit your application to the FDA. After the course, you can take a brief test to receive the certification. Enjoy!
Category: Clinical Trials in US
Length: 01:00
LEARN FOR FREE
This exclusive educational event is reserved to selected Meditrial customers and Meditrial’s staff. With COVID 19, medical device companies are facing increasing complexity to conduct their clinical trials in the US.
Category: Clinical Trials in US
Length: 01:00
Quality Management System for Medical Devices and Clinical Trials
Clinical Trials in USDuration: Unlimited
Cost: 49 USD
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the fundamental concepts of global quality for medical devices and clinical trials. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.
Category: Clinical Trials in US
Length: 00:20
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
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)Duration: Unlimited
Cost: 49 USD
This course is on Clinical performance Studies under the ISO 20196:2019. This
ISO standard describes in detail the requirements for the planning and
conducting of clinical performance studies.
Category: New In Vitro Device Regulation (IVDR)
Length: 00:20
LEARN FOR FREE
Welcome to this Video Course on Health Economics and Outcomes Research. How companies can apply health economics in the early stages of their product development, and why this has benefits for the business success. This course will cover some basic concepts to review the reimbursement system and define the role of health economics and outcomes research and will focus on how to incorporate health economics in the market access strategy.
Welcome to this Video Course on Health Economics and Outcomes Research. How companies can apply health economics in the early stages of their product development, and why this has benefits for the business success. This course will cover some basic concepts to review the reimbursement system and define the role of health economics and outcomes research and will focus on how to incorporate health economics in the market access strategy.
Category: New Medical Device Regulation (MDR)
Length: 00:15
MDR ROADMAP FOR YOUR CLINICAL TRIALS
New Medical Device Regulation (MDR)Duration: Unlimited
Cost: 179 USD
With the new Medical Device Regulation now in force as of 26 May 2021, Meditrial has organized this live event reserved for our customers and partners, to help you understand what changes impact you and manage the transition for ongoing and new clinical trials.
"Meditrial has been preparing for the MDR for 3 years. Alignment with our customers is key to our joint success. We believe that sharing our learnings with you will facilitate understanding and handling the changes together. With this course, we wish to provide you practical information and answers for your MDR compliance."
Dr. Monica Tocchi
Category: New Medical Device Regulation (MDR)
Length: 01:30
MDR Requirements for device labeling and implant card
New Medical Device Regulation (MDR)Duration: Unlimited
Cost: 49 USD
The Course goes over the newly introduced and detailed guidelines for medical device labels as well as specific regulation for the implant cards.
Category: New Medical Device Regulation (MDR)
Length: 00:20
MDR The New European UDI System (Part 2)
New Medical Device Regulation (MDR)Duration: Unlimited
Cost: 49 USD
The New European UDI System Video Course is designed to help you discover the UDI System and how to navigate the systems principles and structure.
Category: New Medical Device Regulation (MDR)
Length: 00:20
MDR The New European UDI System (Part 1)
New Medical Device Regulation (MDR)Duration: Unlimited
Cost: 49 USD
The New European UDI System Video Course is designed to help you discover the UDI System and how to navigate the systems principles and structure.
Category: New Medical Device Regulation (MDR)
Length: 00:20
MDR FOR DUMMIES
New Medical Device Regulation (MDR)Duration: Unlimited
Cost: 49 USD
This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
Category: New Medical Device Regulation (MDR)
Length: 00:30
Lesson 3 - Design and Conduct Clinical Trials for Transcatheter Occluders ISO 22679
Product Guidelines and StandardsDuration: Unlimited
Cost: 99 USD
VIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Category: Product Guidelines and Standards
Length: 00:30
Lesson 2 - Device Design, Pre-Clinical Testing and Risk MGT
Product Guidelines and StandardsDuration: Unlimited
Cost: 99 USD
VIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Category: Product Guidelines and Standards
Length: 00:30
Lesson 1 - Introduction to ISO 22679
Product Guidelines and StandardsDuration: Unlimited
Cost: 99 USD
VIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Category: Product Guidelines and Standards
Length: 00:30
Transcatheter Cardiac Occluders - ISO 22679 - Complete course
Product Guidelines and StandardsDuration: Unlimited
Cost: 282.15 USD
VIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Category: Product Guidelines and Standards
Length: 01:00
Fastrack to Success: How to Build a Regulatory and Clinical Strategy
Startup and Business PracticesThe goal of this presentation is to provide you with the essential elements for success and to teach you how to apply the information to your project.
Navigating the regulatory process and planning clinical trials can be the most daunting aspect of running your start-up.
Category: Startup and Business Practices