Course overview
Software as a
Medical Device (SaMD)
Format
Virtual
Instructor-Led
Date / Time
Select your dates below
Price
€1,575 pp
Duration
22 Hours
Time
11.30am - 5pm
Time Zone
IST
Course Information
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
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support
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.
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
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).
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
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 11.30 am - 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.