Course overview

ISO 13485:2016
Clause by Clause

This 12 hour course provides you with a thorough understanding of each clause of ISO 13485:2016, the associated requirements and how to implement them with a risk-based approach. You'll also gain a deeper understanding of the relationship between ISO 13485:2016 and other applicable regulatory requirements.
This practical course is delivered virtually using Zoom and is fully interactive, offering you the chance to take part in group activities, participate in polls and download course materials.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

£985

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

We're currently finalising our 2024 course calendar. Register your interest below to be the first to receive new 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 [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 is broken down into topics to enhance clarity and facilitate learning. Here's what you can expect:

Day 1:                                                     
- Overview of ISO 13485:2016
- Overview of Clause 1, 2 & 3

Day 2:                                
- Process and risk-based approach model
- Overview and practical implementation of Clause 4 - Quality Management System
- Overview and practical implementation of Clause 5 - Management Responsibility
- Overview and practical implementation of Clause 6 - Resource management
- Q&A

Learning Objectives

  • Understand the relationship between ISO 13485 and applicable regulatory requirements
  • Achieve an in-depth understanding of each clause and the associated requirements
  • How to demonstrate compliance to ISO 13485
  • Understand how to implement ISO 13485 using a risk-based approach

Who Should Attend? 

This training course is recommended for those that require a deeper understanding of the quality management system standard.

  • Quality and Regulatory professionals
  • Internal Auditors
  • General Managers
  • Those who are looking to attend the 2-day internal auditing course

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.

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Meet your instructor

Rod Beuzeval

Regulatory CoE & 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

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 [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?