Course overview

Medical Device
Risk Management

As our industry becomes increasingly complex, understanding how to navigate risk has become more critical than ever. That's why our best-in-class experts have created a 16-hour course to help you understand the requirements of ISO 14971, and its importance for medical device manufacturers.

This course explores the ISO 14971 standard clause by clause to ensure you thoroughly comprehend the requirements. You'll also gain clarity of how ISO 14971 aligns with the new MDR and IVDR.

This training is fully interactive and offers you the chance to take part in group activities, participate in polls and download course materials. 

Format 

Virtual
Instructor-Led

Date / Time

Select your dates below

Price

€1,100

Duration

16 Hours

Time

1pm - 5pm

Time Zone

GMT

Course Information

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

Training Dates

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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 info@meddevsolutions.co.uk 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

Day 1 
- Risk Definitions
- Understanding misuse
- Introduction to ISO 14971:2019
- Risk management process
- Q&A

Day 2 
- Risk management planning
- Risk acceptability criteria
- Risk Management File
- TR 24971
- Hazard identification
- Hazardous situations
- Harm
- Q&A

Day 3

Learning Objectives

  • Understand the purpose and structure of ISO 14971
  • Understand the key terminology used throughout ISO 14971
  • Describe and understand the elements of an effective risk management process
  • Gain a solid understanding of the different techniques that support risk analysis
  • Explain the documents requirements for the risk file and when updates are required
  • Outline the role of ISO/TR 24971 in risk management

Who Should Attend? 

This training course is recommended for anyone involved in risk management.

  • Regulatory Affairs Professionals
  • Research and Design Engineers
  • Quality Managers Quality Engineers Manufacturing Engineers
  • Internal Auditors
  • Marketing
  • Clinicians

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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"Thoroughly enjoyed the 2 day course! Rod was very insightful and knowledgeable. It was a great experience, that I would highly recommend to any medical professional." 

Ash P

RB
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"The course was very comprehensive considering how large the topic is. I learnt a lot more than I expected to and the knowledge of the lecturer was excellent with a lot of hands on experience and advice." 

Angela H

Sysmex
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"Rod is a great communicator and set up a really good course. You could feel his passion for the field and his vast hands-on experience. I would definitely recommend this course to anyone."

Malene L

Coloplast 
Meet your instructor

Rod Beuzeval

Senior Regulatory Expert & Trainer 

Rod is a Regulatory and Clinical expert with 22 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR, MDSAP, ISO 13485, Risk Management, Clinical Data Evaluation and consulting on projects within this realm. 

Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. 
Rod Beuzeval
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

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 account login details. You can access your payment receipts, course details, learning materials and more in your account! 

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 info@meddevsolutions.co.uk. 

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 upskill on Risk Management?
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