Loading ...

Medical Device Software Regulations and Standards Training

This course provides a foundation for understanding the regulatory landscape for software development within the medical device industry.

Regulations are not much different from one country to another, which means understanding the EU and Medical Device Single Audit Program (MDSAP) countries provides a starting point for most countries where organizations would be marketing. In this class, you will learn the regulatory requirements from the EU, US, and MDSAP countries, including requirements for submissions and software-related guidelines, in addition to the standards associated with software (ISO 13485, ISO 14971, and IEC 62304). The course also provides an overview of cloud computing in a regulated environment, artificial intelligence, and machine learning within the regulations.

Read More Courses
Read Less Courses
Course Dates Course Details Virtual Session Details Related Courses

Course Details

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Identify the deliverables for a software product submission, based on device class
  • Determine the evidence that would be needed to support software regulatory requirements in the EU and MDSAP countries, and IEC 62304 requirements
  • Identify the deliverables for a software product submission, based on device class
  • Describe the regulatory framework for software
  • Describe the IEC 62304 standard requirements for software development
  • Explain the relationship between the software regulatory requirements and the applicable standards
  • Provide an overview of the resources containing the key regulations, standards, and guidance documents

Who Should Attend

This class is recommended for software developers and those involved in non-regulatory functions associated with software. That includes:

  • Software QA Engineers
  • Program Managers (managing software)
  • Software Test Engineers
  • Scrum Master (lead of Agile development)
  • Solution Architects


  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, breakout sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 4 consecutive days. Sessions run daily from 1:00-5:00 p.m. (Eastern Time).

Technical / Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors


Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

REQUEST A PROPOSAL Or ask a question!
Get answers right now. Call
us flag

US OfficeWashington DC


EU OfficeCork, Ireland

eu flag

+353 21 212 8530

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal