Training Features

MedTech Software: Navigating Lifecycle Standards, Global Regulation, and the AI Frontier

Gain a practical understanding of medical device software regulations and lifecycle standards in this IEC 62304 e-learning. Learn how to classify software under MDR and IVDR, apply IEC 62304 and IEC 82304-1, manage software risks, cybersecurity, AI compliance, usability, and global regulatory requirements for SaMD and SiMD solutions.
Format

E-Learning

Level

Intermediate

Trainer

Coenraad Davidsdochter

Exam

Exam and certificate included

Duration

2 hours
10 modules

Price

€ 345 or equivalent currency

IEC 62304 Medical Device Software Lifecycle & Regulatory Compliance Training

Software is rapidly transforming the MedTech industry, from embedded firmware in medical devices to standalone AI-driven diagnostic applications. As software takes on a greater role in clinical decision-making, regulatory expectations have evolved significantly under frameworks such as the EU MDR, IVDR, FDA guidance, and the EU AI Act. This e-learning provides medical device professionals with a practical understanding of how to develop, maintain, and regulate compliant medical device software throughout the entire software lifecycle.

During this e-learning, participants will explore the core principles of IEC 62304 and related standards such as IEC 82304-1, ISO 14971, and IEC 62366-1. The training covers qualification and classification of software, software safety classification, risk management, cybersecurity, AI and machine learning, usability engineering, SOUP management, and post-market maintenance. Through real-world examples and case studies, learners will gain the knowledge needed to build safe, effective, and globally compliant software products for both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this 120-minute training, learners will be able to:
  • Understand SiMD/SaMD Legislation: Identify the position of software in global medical device legislation (primary focus for EU & US). 
  • Qualify and Classify: Determine if software is a Medical Device (MDSW) or IVD, and assign appropriate risk classes and their impact on development effort. 
  • Implement Lifecycle Standards: Apply IEC 62304 (Development & Maintenance) and IEC 82304-1 IEC 82304-2 (Product Safety/Health Apps). 
  • Understand Lifecycle Requirements for Development, Maintenance and Integrate Risk Management: include connection to ISO 14971, software-specific hazards, and management of SOUP items and IEC 62366-1. 
  • Address Modern Frontiers: Navigate requirements for Cybersecurity, AI/ML (including the EU AI Act), and Data Protection (GDPR/HIPAA). 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 2 hours.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is designed for professionals involved in the development, regulatory compliance, quality assurance, validation, and lifecycle management of medical device software and digital health technologies:
  • Software Engineers & Architects: Developers of both SiMD (embedded) and SaMD (standalone). 
  • Quality & Regulatory Professionals: Those needing to understand the impact of legislation (MDR/IVDR) on software manufacturers. 
  • Project Managers: Responsible for projects developing new or updating existing SiMD/SaMD. 
  • Design Engineers: Involved in multidisciplinary projects including a SW development 
  • Product Managers: Responsible for qualification, classification, and lifecycle management. 

Comprehensive Regulatory Expertise

Build a strong foundation in global medical device software regulations and lifecycle standards, including IEC 62304, MDR, IVDR, cybersecurity, usability engineering, AI compliance, and risk management for SaMD and SiMD solutions.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Coenraad Davidsdochter

Coenraad Davidsdochter is a Senior Consultant in Software and Artificial Intelligence with over 20 years of development experience and more than a decade working with QMS, technical documentation, risk management, clinical evaluations, and information security.