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.

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.

Why Comply Guru?

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

More course information is coming soon.

Choose Your Preferred Format
Virtual Learning

Virtual Learning

2 days

OR
In-Person Learning

In-Person Learning

2 days

Course Snapshot
 
Approved By
Comply Guru
Duration
16hrs
Available Format
Virtual or In-Person Learning
Language (s)
English
Price
In-Company Groups

Course Overview

Medical Device Software Regulations and Standards Training

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.

About our Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

 
Why Choose Instructor led Learning

Frequently Asked Questions

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.
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.
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.
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.  
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.
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.
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.
CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020