Medical Devices
Courses tagged with "Medical Devices"
Clinical Evaluation Upgrade to MDR
Clinical Evaluation 2020Time: 39 minutes
Is your Clinical Evaluation ready for the MDR? Discover Meditrial e-learning and avoid delays for market access. Meditrial will guide you with easy steps. Learn at your own pace and reach your goals!
After the course, you can take a brief test to receive your certification. Enjoy!
Scientific Discussion on the treatment of refractory angina.
Dr. Konigstein presents the results of the latest publication on a novel treatment for this challenging clinical problem.
Clinical Trial Information System (CTIS)
Clinical Trials
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!
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.
Parliamo di nuovo del problema delle mascherine, che diventa fondamentale nella fase di ripartenza dopo l’emergenza covid.
Non siamo qui per ripetere quanto già diffuso dalla stampa e su internet, ma focalizzarci su quello che dovrebbe sapere sia chi compra, sia chi produce, soprattutto le aziende riconvertite.
Southern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 Minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Eastern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Western Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Northern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
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
GDPR Compliance
GDPRSLIDE-SHOW
Compliance with the new general data protection regulation (GDPR): the present course explains about EU General Data Protection Regulation (GDPR) issued by the European Parliament and the Council of the EU to strengthen and unify data protection for all
individuals within the EU. The processing of personal data related to EU subjects for the purpose of clinical trials falls within the scope of the GDPR.
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 New Responsibilities of Sponsor/CRO
ISO 14155:2020 GCP for Medical DevicesLevel: Intermediate
Time: 20 Minutes
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.
ISO 14155 2020 Responsibilities of Principal Investigator
ISO 14155:2020 GCP for Medical DevicesLevel: Intermediate
Time: 20 Minutes
This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities
ISO 14155 2020 Masterclass
ISO 14155:2020 GCP for Medical Devices
ISO 14155 2020 Ethical Considerations
ISO 14155:2020 GCP for Medical DevicesThis tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for Ethics and the informed consent process.
ISO 14155 2020 Clinical Trial From Start To Finish
ISO 14155:2020 GCP for Medical DevicesLevel: Intermediate
Time: 35 Minutes
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout.
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?
10. Privacy, GDPR e Medical Device
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
9. ITALIA: Normative e Procedure di approvazione, gestione centri, monitoraggio e report di sicurezza
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
8. Digital Health, eCRF/ePRO, Data Management, Cybersecurity
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
7. ISO 14155: il monitoraggio per i Medical Device in pratica
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
6. ISO 14155 Conduzione dello studio dalla A alla Z
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
5. ISO 14155 Fondamenti, Disegno e pianificazione dello studio, la documentazione
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
4. EUROPA i Trial Clinici, le nuove regole, cosa cambia e come prepararsi
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
3. EUROPA Nuovo Regolamento: panoramica e punti critici per le CRO
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
2. Orizzonti del Medical Device, Regolamenti Globali, Roadmap to Market
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
1. Il mondo del medtech, biotech e digital health - capire la classificazione e il mercato
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)
Medical Device Day
New Medical Device Regulation (MDR)L’Università degli Studi di Roma Tre e Meditrial presentano una giornata dedicata al mondo dei Medical Device all’interno del Master Sociosanitario. Le testimonianze di esperti, protagonisti nel settore sanitario, socio-sanitario e socio-educativo, racconteranno l’evoluzione del panorama globale in ambito MDR a livello clinico e regolatorio.
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 ROADMAP FOR YOUR CLINICAL TRIALS
New Medical Device Regulation (MDR)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.
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)
INTRODUCTION TO MEDICAL DEVICE REGULATION ROADMAP & ORIENTATION
New Medical Device Regulation (MDR)This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. 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!
INNOVAZIONE NEL MONDO DELLA RICERCA CLINICA
New Medical Device Regulation (MDR)
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.
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.
EUDRAVIGILANCE CERTIFIED TRAINING
PharmacovigilanceYou will understand the European regulation, familiarize with the general terms, and learn the mandatory data elements necessary for the electronic submission of safety information on medicinal products.
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
Startup Governance: A 10-Step Guide for innovators and board members
Startup and Business PracticesHow to run a startup successfully? The success of your business depends on the mix of innovative ideas and skilled board members. This video course will offer you a 10-Step Guide to quickly understand what you need to do to accomplish your goals and achieve the business targets for your MedTech company.
