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FDA and EU Medical Device Software Regulations and Standards Training

This course provides a foundation for understanding the regulatory landscape for medical device software development. In this class, you will learn the regulatory requirements from the EU, US, and MDSAP countries including Australia, Canada, Brazil, and Japan. We cover requirements for submissions and software-related guidelines, plus 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, plus current regulatory guidelines related to artificial intelligence and machine learning. Looking for more focus on IEC 62304? Consider this class

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Brief Overview of This Medical Device Software Regulations Course

SkillsLab Class ?

Class Content


Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming FDA and EU Software Compliance Training Classes

SkillsLab $2995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
RAS VIRTUAL DELIVERY (Eastern Time) 30 Apr 2024 03 May 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
RAS VIRTUAL DELIVERY (Eastern time - PM) 18 Nov 2024 21 Nov 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Medtech Software Regulations Course

The course covers the regulatory requirements from US FDA, EU, and other major international regulators. We dive into the requirements for submissions and software-related guidelines, plus standards associated with software including ISO 13485, ISO 14971, and IEC 62304. 

Course Overview
SkillsLab Class

Software Regulatory Introduction

  • 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)

Regulatory Requirements Related to Software

  • 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)
Exercise! Check Your Understanding

Software Guidance

  • FDA guidance
  • EU guidance
  • Global guidance
Exercise! Guidance Deep Dive

Standards Associated with Software

  • ISO 13485
  • IEC 62304
  • IEC 82304
  • ISO 14971
  • ISO 27001
Exercise! Standards / Regulations Crosswalk

Regulatory Submissions

  • Premarket submission guidance
  • Documentation level
  • Software submission documentation
  • Cybersecurity documentation
  • Other premarket submission documentation
Exercise! Identify the Deliverables for a Product Submission
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

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

Who Should Attend

This class is recommended for regulatory and quality roles related to software development, software developers, and those involved in nonregulatory functions associated with software, including software QA engineers, program managers (managing software), software test engineers, scrum masters (leads of Agile development), and solution architects.

  • Software Development Teams
  • Scrum Masters
  • Software QA Engineers
  • Program Managers
  • Software Test Engineers 

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