Course overview

Software as a
Medical Device (SaMD)

Our industry-leading experts have created a 22-hour course to help you understand the requirements of IEC 62304 and the importance for medical device manufacturers.

This course explores the IEC 62304 standard clause by clause to ensure a thorough understanding of the requirements.

During this course, you will be provided with an  understanding of how IEC 62304 aligns with Design Control and Risk Management towards meeting the new European MDR and IVDR and the US requirements of FDA 21 CFR 820, QMSR.
Format 

Virtual
Instructor-Led

Date / Time

Select your dates below

Price

€1,575 pp

Duration

22 Hours

Course Information

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

  • 11 - 14 March, 2024, 11:30 – 5pm GMT - Book Now
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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

This training course will explore the following topics:

Day 1 - Regulatory Overview
- ISO 13485 Software Requirements
- MDR 2017/745 / IVDR 2017/746 Software Requirements
- MDR (UK) 2002 Software Requirements
- FDA 21 CFR Part 820
- MDCG Guidance / Consensus Guidance

- Software Definitions
- Software Development Life Cycle (SDLC)
- Software Classification
- Security & Data Protection


Day 2 - Practical
- Software Development Planning
- Intended Use & User Needs

Learning Objectives

  • Understand the purpose and structure of IEC 62304
  • Understand the key terms and definitions used through IEC 62304 (incl. SaMD, Software as a component or accessory, embedded software)
  • Describe and understand all elements of IEC 62304 and the deliverables required based on Software Risk Classification
  • Understand the interconnection between Software Development, Design Control and Risk Management and Human Factors/Usability Engineering
  • Explain with working examples the key deliverables required from IEC 62304
  • Understand when IEC 60601 is required
  • Identify Label Requirements for Software including UDI

Who Should Attend? 

  • Software Engineers
  • Software Managers
  • Quality Managers
  • Design Assurance
  • Managers Software
  • Quality Engineers
  • Quality Engineers
  • Regulatory Affairs Professionals 
  • Internal Auditors

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.

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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''Thanks to this training, I now feel more confident and equipped to navigate the challenges of developing and maintaining SaMD products. I have already started implementing the knowledge gained from the training into my current projects, and I can see the positive impact it has had on our processes.''

Chloe B

MediGlobal 
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''The trainers demonstrated deep expertise in the subject matter and effectively communicated complex concepts in a clear and concise manner. The training materials provided were also top-notch, offering practical examples that enhanced my understanding of SaMD development and regulatory requirements.''

Sean H

Cambridge University 
Meet your instructor

Niamh Lynch 

SaMD Trainer 

Niamh has amassed extensive knowledge & experience over 20+ years’ in the life sciences, leading Design Control, Risk Management and Computer System Validation and Regulatory Teams to successful regulatory acceptance for companies such as Boston Scientific, Merit Medical, Johnson & Johnson, Mylan and Olympus. Her experience spans greenfield sites, start-ups, medium and multinational organisations before moving to Regulatory Body.

Niamh became a leading risk and software trainer as a lead technical CE mark reviewer for NSAI Medical Device Notified Body specialising in MDR, Risk Management, Software & New Technologies, including Active Devices under IEC 60601 & IEC 62304. Niamh supported the 1st generation guidance for SaMD developed by the MDCG New Technology Group set-up by the EU Commission for identification of software requirements related to healthcare applications and new emerging technologies (AI).

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

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. 

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 SaMD?