Training Features

AI-IVD Devices: Lessons from Manufacturers

This 2-hour, self-paced e-learning course provides a practical, manufacturer-focused exploration of the AI-IVD lifecycle, helping learners successfully build AI requirements into their existing Quality Management System (QMS) and performance evaluation frameworks.
Format

E-Learning

Level

Intermediate

Trainer

Coenraad davidsdochter

Exam

Exam and certificate included

Duration

2 hours
8 modules

Price

€ 345 or equivalent currency

Course Overview & Description

Artificial Intelligence and Machine Learning (AI/ML) are revolutionizing the In Vitro Diagnostics (IVD) market, driving an unprecedented shift toward precision medicine, digital pathology, and automated workflows. However, bringing an AI-enabled IVD device to global markets requires navigating a complex web of technical hurdles, evolving quality management expectations, and strict regulatory frameworks like the EU IVDR and the EU AI Act.  

This 2-hour, self-paced e-learning course provides a practical, manufacturer-focused exploration of the AI-IVD lifecycle. Grounded in Qserve’s extensive real-world project experience and direct industry data, the training bridges the gap between technical data science and clinical/regulatory compliance. It highlights exactly what works, what fails in the field, and how to successfully build AI requirements into your existing Quality Management System (QMS) and performance evaluation frameworks.  
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this course, learners will be able to: 
  • Identify Global Trends & Technologies: Recognize key growth drivers, market numbers, and emerging AI paradigms (e.g., Explainable AI, Edge AI, Federated Learning) shaping the IVD landscape.
  • Anticipate Technical & Workflow Pitfalls: Uncover common failure modes in data heterogeneity, label noise, and laboratory information system (LIS) integration.
  • Implement Compliant Data Strategies: Describe the strict requirements for separating training, validation, and testing datasets as mandated by global regulators.
  • Integrate AI into Performance Evaluations: Apply the three-pillar framework of the IVDR (Scientific Validity, Analytical Performance, Clinical Performance) directly to AI algorithm behaviors.
  • Navigate Quality & Regulatory Changes: Adapt a standard QMS using the Team-NB AI Questionnaire and safely anticipate the shifting timelines of the EU AI Act and GDPR updates.
  • Mitigate Cybersecurity & Supplier Risks: Assess unique AI vulnerabilities (e.g., data poisoning, evasion attacks) and manage dynamic AI Software of Unknown Provenance (AI SOUP).
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. 120 minutes.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is specifically designed for beginner to intermediate level professionals working within or alongside the medical device and IVD manufacturing sectors worldwide, including:  
  • Regulatory Affairs (RA) Specialists & Managers looking to understand the intersection of IVDR performance evaluations and AI Act compliance.
  • Quality Assurance (QA) Engineers tasked with updating standard operating procedures (SOPs) for data governance, model drift, and supplier controls (AI SOUP).  
  • AI/ML Engineers & Software Developers entering the medical/clinical laboratory space who need to understand why "black-box" models fail clinical and regulatory scrutiny.  
  • Product Managers & Clinical Scientists designing performance evaluation plans (PEPs) for intelligent diagnostic software.  

Comprehensive Regulatory Expertise

Gain recognized certification, advance your regulatory career, and learn at your own pace with a flexible learning schedule designed for medical device professionals.
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, a Senior Consultant in Software and Artificial Intelligence, brings over 20 years of software development experience and more than a decade in establishing and managing Quality Management Systems (QMS) compliant with ISO 13485, MDD 93/42/EEC, MDR 2017/745, and GDPR 2016/679, and has extensive expertise in areas such as technical file documentation, risk management, clinical evaluations, and information security.