Medical Device Software Regulations and Standards Training

16hrs Instructor-led Learning

Medical Device Software Regulations and Standards Training that provides a foundation for understanding the regulatory landscape for medical device software development (FDA, EU and MDSAP Countries). Plus, it will include an overview of cloud computing in a regulated environment, plus current regulatory guidelines related to artificial intelligence and machine learning.

More course information is coming soon.

Why Comply Guru?

Highly Interactive, Engaging Experience
Industry-leading Accelerated Learning Methodology
Delivered by Experts with Proven Expertise

Course Overview

Medical Device Software Regulations and Standards Training

Our training is for anyone that wants an understanding the regulatory landscape for medical device software development, and it can be completed in-person or virtually.

Available Formats:

Virtual Learning

Face to Face Learning

What Will I Learn?

A summary of topics within this course include:

Key terms
Current trends / issues in software development in medical devices
Artificial intelligence (AI)
Machine learning (ML)
Cloud-based computing
Cybersecurity
Benefits of Agile
Continuous integration and continuous delivery / continuous deployment (CI/CD)
Software as a medical device (SaMD) vs. software in a medical device (SiMD)
EU Medical Device Regulation (MDR)
MDSAP (country by country)
Relationship to other global jurisdictions
Software bill of materials (SBOM)
FDA guidance
EU guidance
Global guidance
ISO 13485
IEC 62304
IEC 82304
ISO 14971
ISO 27001
FDA 510(k) submission guidance
Level of concern
Software submission documentation
Cybersecurity documentation
Other premarket submission documentation

Will I Get A Certificate?

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

How Will I Be Assessed?

In order to successfully complete this course, each Learner will need to:

Fully attend the Live Instructor Workshop as 100% attendance is required

What Are The Technology Requirements?

If you are completing this training virtually, the following applies:

For the live workshops during a virtual delivery, we utilize both Zoom and Microsoft Teams.

Learners need to individually have:

PC or MAC Computer
Reliable Internet
Video Webcam
Headset or Earbuds
Quiet Setting

In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Pricing

Gain a Recognized Qualification

Advance your knowledge and upskill with one of our Instructors.

Need a group quote?

Contact Sales

Frequently Asked Questions

What is blended learning?

A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.

When do I get access to the eLearning modules?

The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.

Can I transfer to different workshop dates?

Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.

What technology/application is used for this training?

For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

What is the maximum number of learners in the live workshops?

We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.

Do we offer in-house / private training?

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.

Will I receive a course certificate?

Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

Related Training Courses

ISO 14971 Foundation Training

8 hours

€ 495.00

Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training

16 hours