Video Course
Courses tagged with "Video Course"
Clinical Trial Information System (CTIS)
Clinical Trials
Good Clinical Practice for Drugs and Medical Devices
Clinical TrialsTime: 15 Minutes
This lecture describes covers the basic concepts that are important to understand in clinical research for different medical products.
6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS
Clinical Trials for Medical Devices in Europe
5. MDR SUBSTANTIAL STUDY CHANGES, TEMPORARY HALT AND TERMINATION
Clinical Trials for Medical Devices in Europe
4. MDR STUDY APPLICATION AND APPROVAL - NEW COORDINATED ASSESSMENT
Clinical Trials for Medical Devices in Europe
3. MDR CONDITIONS, ETHICAL PRINCIPLES, METHODS, INFORMED CONSENT
Clinical Trials for Medical Devices in Europe
Clinical Trials for Medical Devices in Europe - COMPLETE TRAINING PROGRAM
Clinical Trials for Medical Devices in Europe
1. MDR NEW DEFINITIONS AND TYPES OF TRIALS
Clinical Trials for Medical Devices in Europe
2. MDR THE ACTORS: SPONSOR, INVESTIGATOR & SUBJECT
Clinical Trials for Medical Devices in EuropeThis course presents an overview of the "actors" within the scope of the new MDR, namely the sponsors, investigators, and subjects. Learn all you need to know about how these "actors" play a significant role within the new MDR.
After the course, you can take a brief test to receive your certification. Enjoy!
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
Clinical Trials in US
Clinical Trials During COVID-19
Covid-19Video Course
Time: 22 Minutes
HOW TO FIND AND EFFECTIVELY USE PREDICATE DEVICES
FDA Medical Device Regulation for Everyone
FDA IVD REGULATION
FDA Medical Device Regulation for Everyone
FDA EARLY FEASIBILITY STUDY PROGRAM
FDA Medical Device Regulation for EveryoneWe 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.
510(k) Submission Process
FDA Medical Device Regulation for Everyone
FDA Q-Submission Process
FDA Medical Device Regulation for Everyone
Breakthrough Device Designation
FDA Medical Device Regulation for Everyone
Emergency Use Authorization (EUA)
FDA Medical Device Regulation for Everyone
De Novo Classification Pathway
FDA Medical Device Regulation for Everyone
FDA Clinical Laboratory Improvement Amendments (CLIA)
FDA Medical Device Regulation for Everyone
FDA Safer technology program (STeP)
FDA Medical Device Regulation for Everyone
FDA Premarket Approval (PMA)
FDA Medical Device Regulation for Everyone
LEARN FOR FREE
RECORDED LIVE LECTURE - Dr. M. Tocchi
Time: 15 Minutes
This recorded video-lecture by Dr. Monica Tocchi, who contributed to the development of international standard ISO 14155 for clinical trials. This introductory course describes the key changes that affect pre-market studies and post-market trials for medical devices.
ISO 14155 2020 Masterclass
ISO 14155:2020 GCP for Medical Devices
MDR/MPDG Update Course - Online
Medical Device Clinical Trials in Germany - MPG CME Certified CoursesDer Update-Kurs richtet sich an Hauptprüfer, Prüfärzte und Studienpersonal in klinischen Prüfungen, die ein gültiges MPG-Zertifikat besitzen und die Teilnahme an klinischen Prüfungen unter der neuen EU-Medizinprodukteverordnung und der ISO 14155:2020 beginnen oder fortsetzen wollen.
Der Schwerpunkt des Kurses liegt darin, Sie mit den wichtigsten Änderungen, die sich mit Einführung der EU-Verordnung 2017/745, dem MPDG und der ISO 14155:2020 ergeben, vertraut zu machen.
MPG Auffrischungskurs - Onlinekurs
Medical Device Clinical Trials in Germany - MPG CME Certified CoursesDer Auffrischungskurs richtet sich an Hauptprüfer und Prüfer bei klinischen Prüfungen, die bereits einen MPG Grundlagenkurs absolviert haben, jedoch über einen Zeitraum von drei Jahren keine aktive Beteiligung an klinschen Prüfungen nachweisen können.
Inhouse-Schulungen oder Live-Webinar auf Anfrage.
Sind Sie interessiert?
MPG Grundlagenkurs - Onlinekurs
Medical Device Clinical Trials in Germany - MPG CME Certified CoursesDer Kurs soll Ihnen das rechtliche, ethische und methodische Wissen vermittelten, um als Prüfer oder Mitglied der Prüfgruppe tätig werden zu können. Dabei legen wir Wert darauf, dass wir Ihnen neben den reinen Fakten auch Methoden und Werkzeuge in die
Hand geben, die Ihnen eine kompetente und konforme Durchführung von Studien mit Medizinprodukten ermöglichen.
Inhouse-Schulungen oder Live-Webinar auf Anfrage.
Sind Sie interessiert?
In Vitro Medical Device Regulation Roadmap (IVDR)
New In Vitro Device Regulation (IVDR)In this course, we will cover all the necessary regulatory references. We will discuss in details an article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)
European IVDR Masterclass
New In Vitro Device Regulation (IVDR)
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.
MDR Requirements for device labeling and implant card
New Medical Device Regulation (MDR)
MDR The New European UDI System (Part 2)
New Medical Device Regulation (MDR)
MDR The New European UDI System (Part 1)
New Medical Device Regulation (MDR)
MDR EUDAMED The European Database for Medical Devices and IVDS
New Medical Device Regulation (MDR)This video course presents the European Database for Medical Device and in vitro diagnostic device and provides key information in order to become familiar with the new electronic system for data storage. Learn all you need to know regarding the new Electronic database system.
MDR FOR DUMMIES
New Medical Device Regulation (MDR)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.
Post-Market Clinical Follow-Up
New Medical Device Regulation (MDR)This lecture describes the key changes regarding post market clinical follow-up and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
Post-Market Surveillance for Medical Devices in Europe
New Medical Device Regulation (MDR)Video Course
Time: 25 Minutes
This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations.
After the course you can take a final test to receive your certification. Enjoy!
Medical Device Regulation Roadmap And Orientation
New Medical Device Regulation (MDR)RECORDED LIVE LECTURE - Dr. M. Tocchi
Time: 58 minutes
This lecture presents the roadmap of the new European regulation for medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
After the course, you can take a brief test to receive your certification. Enjoy!
MDR Fundamentals
New Medical Device Regulation (MDR)Welcome to the Meditrial MDR Fundamentals. In three easy VIDEO-COURSES, you will learn all the essential information regarding the MDR changes and the new procedures for Clinical Evaluation and clinical trials, including a learning module on the new standard 14155. Get ready to learn all you need to know on the new European regulation for medical devices. After the courses, you can take a brief test to receive your certification. Enjoy!
New Medical Device Regulation (MDR) Master Class
New Medical Device Regulation (MDR)Access Meditrial Academy to learn quickly and easily the details of the new Medical Device Regulation (MDR) 745/2017. Everything you need to know about the MDR and how to apply it to devices and companies.
The Pharmacovigilance System in Europe - Chinese
PharmacovigilanceIn response to the global need for training in pharmacovigilance and the regulation changes in Europe, Meditrial has developed a series of e-learning courses covering different aspects of the science of medicines safety.
Meditrial’s e-learning courses take a micro-learning approach, with short, concise lessons connected to clear learning objectives. Most courses are taught in English, with subtitles in English. Courses are also available in other languages such as German, Italian and Chinese. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
The broad collection of self-paced e-learning courses is suitable to health professionals with an interest in pharmacovigilance. Courses are made available free of charge to those working at pharmacovigilance centres or in the public sector (hospitals, pharmacies, academia etc.). For those working at for-profit organisations or companies (pharmaceutical companies, contract research organisations etc.), the courses will be made available for a fee. Please visit our e-learning platform to enrol and learn more about the course content.
European Pharmacovigilance and Drug Safety Training
PharmacovigilanceIn response to the global need for training in pharmacovigilance and the regulation changes in Europe, Meditrial has developed a series of e-learning courses covering different aspects of the science of medicines safety.
Meditrial’s e-learning courses take a micro-learning approach, with short, concise lessons connected to clear learning objectives. Most courses are taught in English, with subtitles in English. Courses are also available in other languages such as German, Italian and Chinese. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
The broad collection of self-paced e-learning courses is suitable to health professionals with an interest in pharmacovigilance. Courses are made available free of charge to those working at pharmacovigilance centres or in the public sector (hospitals, pharmacies, academia etc.). For those working at for-profit organisations or companies (pharmaceutical companies, contract research organisations etc.), the courses will be made available for a fee. Please visit our e-learning platform to enrol and learn more about the course content.
Lesson 3 - Design and Conduct Clinical Trials for Transcatheter Occluders ISO 22679
Product Guidelines and StandardsVIDEO 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
Lesson 2 - Device Design, Pre-Clinical Testing and Risk MGT
Product Guidelines and StandardsVIDEO 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
Lesson 1 - Introduction to ISO 22679
Product Guidelines and StandardsVIDEO 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
Transcatheter Cardiac Occluders - ISO 22679 - Complete course
Product Guidelines and StandardsVIDEO 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
