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.
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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.
Face to Face Learning
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
- 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
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
In order to successfully complete this course, each Learner will need to:
- Fully attend the Live Instructor Workshop as 100% attendance is required
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.
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