Understanding Medical Device Software Requirements in the EU and US

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Course Overview


Medical device software is evolving and growing exponentially. As technology advances, more innovative software solutions are brought to market such as apps, embedded software, cloud based, big data, artificial intelligence (AI) and machine learning. As a result, regulatory requirements are constantly changing to ensure patient safety.


This training course will provide you with a practical understanding of the European and US regulatory requirements for medical device software. Once completed, you will have the skill and confidence to get your software product on the European and US markets. The course also examines areas such as clinical evaluations, investigations, post market surveillance and risk management – specifically for software.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Understand how to apply the MDR classification rules for software
  • Gain a comprehensive overview of the EU and US regulatory framework for software products
  • Understand the safety and performance requirements imposed by law on medical device software manufacturers
  • Learn what evidence to collect for approval in the US and EU – discover how to compile a technical file and clinical evaluation report
  • Critically analyse how neural networks, machine learning, and autonomous systems challenge classical safety processes and principles
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

Using the regulations and definitions to determine if your product is a device

  • Medical device definitions
  • In-vitro diagnostic software
  • Multi-functionality software
  • Cloud computing and software as a service
  • Intended purpose and excluded functionality
  • Companion diagnostics, medication management and adherence apps
  • Population health and educational software
  • Resource and workflow management vs clinical decision support software
  • Clinical decision software
Module 2

Software classification

  • Implementing the classification rules on software
  • Software that drives or influences the use of a (hardware) medical
  • Borderline with lifestyle and fitness software
  • Borderline with pharmaceuticals, combination products
  • IMDRF SaMD risk type determination
Module 3

Placing a medical device software in the EU market

Examine the regulatory requirements to put a medical device software on the European market. You will examine the Medical Device Regulation (MDR).

  • Engaging with a Notified Body
  • Controlling software suppliers and subcontractors
  • UDI number and EUDAMED
  • Declaration of Conformity
  • Person responsible for regulatory compliance (PRRC)
  • Software traceability
  • App stores and digital distribution platforms
Module 4

Placing a medical device software in the US market

Examine the regulatory requirements to put a medical device software on the market. You will examine the 510(k) process and various FDA software guidances

  • US Code of Federal Regulations and its’ implications for software
  • 510(k) process
  • FDA guidance for software
  • Practical construction of a 510(k)
  • Challenges faced for app developers to have their app taken up in care pathways
  • Quality and reliability of health and wellness apps
  • Evolving policy and reimbursement landscapes for digital health technologies
Module 5

Clinical evaluations

  • Defining a scope and a sufficient level of clinical evidence for medical device software
  • Role of validation and usability
  • Considerations for artificial intelligence and continuous learning software


Module 6

Clinical investigations

  • General principles of clinical investigations
  • When is a clinical investigation needed for medical device software
  • Selecting appropriate study design
  • Clinical performance studies
  • Generating evidence of effectiveness
Module 7

Safety risk management – ISO 14971

  • Applying an effective risk management strategy for medical device software



Module 8

Post-Market Surveillance for medical device software

  • Post-market regulatory requirements
  • Components of an effective PMS
  • Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting
  • Implementation of Post Market Clinical Follow-up for medical device software
  • Real-world evidence
  • Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working



The course is designed for professionals who must understand the regulatory requirements of medical device software products such software-only products, hardware product with embedded software, health apps and medical device software. These include:

  • Regulatory Affairs
  • Project and Product Management
  • Software Architects
  • Designers and Developers
  • Research & Development Management
  • Requirements Engineers
  • Verification, Validation and Clinical Evaluation Specialists
  • Usability Experts
  • Cybersecurity Experts
  • Risk Management Moderators
  • Quality and Regulatory Specialists
Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.