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IVDR Training : In Vitro Diagnostic Medical Devices Regulation 2017/746

5/5
(55 reviews)
IVDR-2017746

Duration :

2

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 : IVDR Training : In Vitro Diagnostic Medical Devices Regulation 2017/746

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:

Are you aware of how the new EU IVDR will impact your business? It affects all economic operators in the supply chain, including manufacturers, distributors, importers, and authorized representatives. Compliance with IVDR is mandatory to ensure market access and maintain regulatory approval. To help your organization comply with the new IVDR requirements, GxP Training is offering an online certified course with 9 modules.

 

Who should enroll?

This course is designed for professionals in the IVD medical device sector. It is ideal for those in regulatory affairs, design & development, quality management/assurance, quality engineering, internal auditing, authorized representatives, and PRRCs.

 

Learning Objectives: 

By the end of this course, participants will be able to:

  • Understand the EU IVDR 2017/746 framework
  • Identify and classify IVD medical devices
  • Recognize the roles and responsibilities of economic operators
  • Explain General Safety & Performance Requirements (GSPR)
  • Understand ongoing compliance requirements (post-market surveillance and vigilance reporting)
  • Describe technical documentation and UDI requirements

 

A certified course by GxP Training offers a highly interactive learning experience. Each session integrates real-life examples and quizzes. Upon completion, participants will receive a globally acknowledged training certificate, accredited with CPD/CEU credits.

 

Curriculum:

Introduction

Lesson 1: Overview of the Regulation

Lesson 2: What is an In Vitro Diagnostic Medical Device?

Lesson 3: Classification of In Vitro Diagnostic Medical Device

Lesson 4: Economic Operator

Lesson 5: EUDAMED

Lesson 6: UDI & Registration

Lesson 7: Conformity Assessment

Lesson 8: Sufficient Clinical Evidence

Lesson 9: Post Market Surveillance

Conclusion

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:

5/5
(55 reviews)
The 'IVDR 2017/746' training clarified complex regulations and helped ensure our IVD devices meet compliance standards. I recommend this training to all my clients.
Laura MitchellRegulatory Affairs Consultanrt
USD: United States (US) dollar ($) ^

$95

Buy now

  Large group ? Request a quote !

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.
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$95.00 / year

$95.00 / year

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About us

GxP Training is a service provided by Axeda SRL, a recognized leader in digital regulatory learning. Axeda specializes in compliance training and assessment solutions specifically designed for life sciences companies and professional training organizations.

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