Medical Device Regulation – MDR 2017/745

4.5/5
29
MDR 2017

Duration :

2

1 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 ourย 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:

ciaran
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
USD: United States (US) dollar ($) ^

$60

Buy now
This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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