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Medical Device Regulation – MDR 2017/745

 4.5/5

29

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Discover the comprehensive regulations of the European Union’s Medical Device Regulation (MDR) 2017/745 with our interactive course. We delve into the intricate laws governing medical device safety, efficacy, and quality – covering topics from market release requirements to identification and traceability methods.

The course also explores the role of notified bodies, conformity assessments, clinical evaluations, and more. Crucially, you’ll learn about post-market surveillance practices, vigilance, market surveillance, and the use of the European Database on Medical Devices (Eudamed).

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Introduction

Lesson 1: Lesson 1: Scope and Objectives of MDR 2017/745

Lesson 2: Regulation Outline – Chapters and Annexe

Lesson 3: Requirements for Market Release

Lesson 4: Identification and Traceability

Lesson 5: Notified Bodies

Lesson 6: Conformity Assessment

Lesson 7: Clinical Evaluation and Clinical Investigation

Lesson 8: Post-Market Surveillance, Vigilance and Market surveillance

Lesson 9: European Database on Medical Devices (Eudamed)

Glossary

Evaluation

Author:

Dr. Ciaran McEnister

Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

 4.5/5

29

The Medical Device Regulation - MDR 2017/745 course offers a comprehensive and practical guide to the complex EU regulatory environment. It blends theory with real-world applications, providing interactive and engaging content developed by experienced professionals. A must-take course for anyone involved in the medical device industry!

$60

Buy now

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.