Course overview

Clinical Evaluation
for Medical Devices

Are you struggling to understand the clinical evaluation requirements under the EU MDR?

This 16-hour in-depth training course will give you the necessary skills to ensure all the requirements of the EU MDR are met and provide an insight into how clinical evaluation is integrated with risk management and post-market surveillance including best practices and the pitfalls to avoid.

This course is delivered virtually using Zoom and is fully interactive, offering you the chance to take part in group activities, participate in polls and share and download course materials.

Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

€1,100

Duration

16 Hours

Time

1 pm - 5 pm

Time Zone

GMT

Course Information

Course Syllabus 
Dates & Prices
What's Included
Technology Requirements
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Training Dates

Training Times

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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Course Agenda

This training course will explore the following topics:

Module 1: What is Clinical Evaluation?                                                       
- Definitions and Key Terminology
- Clinical Evaluation and the MDR
- What has changed under the MDR?
- Post Market Clinical Follow-up (PMCF)

Module 2: Guidance for Clinical Evaluation                                            
- Links to other processes
- Clinical Data Evaluation

Module 3: Clinical Evaluation Plan
 
- Plan Objectives, Sources of Data & Claims
- ERs/GSPRs

Learning Objectives

  • Understand the additional requirements for clinical evaluation imposed by the MDR 2017/745
  • Know how to address continuous updates of a clinical evaluation report in a practical way
  • Understand where clinical evaluation fits in the legal framework
  • Gain effective techniques for establishing that sufficient Information is presented in a CER
  • Gain a solid understanding of what your QMS needs to cover

Who Should Attend? 

This course is recommended for anyone involved in implementing or maintaining a clinical evaluation file.

  • Quality Engineers
  • Quality Managers
  • Regulatory Professionals
  • Clinical Data Evaluators
  • Clinical Sponsors

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

Get your training agenda

Simply fill in the form to access your training agenda now.

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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Meet your instructor

Dr Steve Curran

Senior QA/RA Expert & Trainer 

Dr Steve Curran is Senior QA/RA Expert at Meddev Solutions.
Steve holds a PhD in Clinical Engineering, and has worked as a research engineer, project manager and a regulatory and quality assurance professional. With an extensive background in manufacturing process engineering, medical device design and global regulatory and quality affairs for the medical device industry, he has significant experience managing projects from concept to completion as a senior leader.

His career has been truly global. Steve spent five years in managerial positions, before working as Lead Technical Auditor with a major Notified Body for eight years. More recently, he worked as Head of Regulatory & Quality Affairs at a medical device company, before ultimately spending three years as Compliance Director in the area of orthopaedics.

Steve brings a wealth of experience to this role, with significant involvement in auditing and compliance. He has also presented at a number of international conferences on biomaterials, tissue engineering and regenerative medicine and has published several peer reviewed papers in these areas.
Rod Beuzeval

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

Get your training agenda

on-demand webinar

Clinical Evaluation for Medical Devices: What is Clinical Evaluation and Why is it Important?

Is medical device clinical evaluation still a mystery to you? Are you unsure of what is required? Would you like to know what documentation you are expected to create?

If you are new to clinical evaluation for medical devices, this detailed webinar breaks down what you need to do as a manufacturer, explains how clinical evaluation links with other processes and what guidance is available to you.

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Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your course overview, login details, course agenda and payment receipts. You can begin your training immediately!

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence-approved industry expert. You can ask questions throughout the course as if you were in a real classroom. 

What time is this course?

We run this course from 1 pm - 5 pm GMT. If you can't make the live sessions, don't worry. We will record them, so you can catch up on anything you've missed!

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
Ready to get started?