1. Regulatory Competence in the Laboratory: From CE Marking to In-House Testing
   This course offers a hands-on overview of regulatory requirements in the laboratory environment, focusing on IVDR, quality assurance, and approval processes. Participants will learn how to use diagnostic tests safely and in compliance with regulations through practical case examples.
   (Available soon)
   
   

2. Introduction to Regulation and the World of In-House IVDs: Significance and Application in Diagnostics

   This course provides practical insights into the regulatory requirements for In-House IVDs (LDTs), considering the IVDR and ISO 5649. Participants will learn about the entire lifecycle of an LDT and how to implement legal requirements in daily lab operations.
   (Available soon)
   
   

3. Quality Management Systems (QMS): Deep Dive and Optimization for LDTs

   This course practically conveys the regulatory requirements for quality management systems for In-House IVDs under IVDR, ISO 15189, and ISO 5649. Participants learn how to create the necessary documentation and securely implement regulatory processes such as change management and audits, ensuring that development and manufacturing of In-House IVDs are adequately covered by the QMS.
   (Available from: September 2025)
   
   

4. From Intended Use to Use Purpose: The Foundation for Regulatory Compliance and Clinical Relevance

   This course teaches how to formulate and systematically apply intended purposes within the framework of the IVDR, incorporating all relevant elements. Practical examples and exercises demonstrate the link with risk management, performance evaluation, and documentation strategies for in-house IVDs.
   (Available soon)
   
   

5. General Safety and Performance Requirements – The Role of GSPRs in the Laboratory

   This module provides practical knowledge of the General Safety and Performance Requirements (GSPRs) of the IVDR and their relevance for diagnostic laboratories, particularly for in-house tests. It explains the three chapters of the GSPRs – general requirements, design & manufacturing, and information for users – and demonstrates through concrete examples how labs can implement these in documentation and compliance. Step-by-step guides, checklists, and case studies facilitate practical application. The goal is to empower laboratory staff to understand and implement regulatory requirements confidently.
   (Available from: September 2025)
   
   

6. Performance Evaluation According to ISO 5649 – Introduction to Validation and Verification

   This course teaches the basics of performance evaluation for LDTs, including validation, verification, and relevant performance characteristics in line with IVDR and ISO 5649. Participants will learn to create solid validation and verification plans and confidently implement regulatory requirements.
   (Available from: September 2025)
   

7. Risk Management

   This course teaches the fundamentals of risk management for in-house tests throughout the entire test lifecycle. Participants learn to systematically identify, assess, and implement control measures practically to ensure patient safety and quality management.
   (Available from: November 2025)
   
   

8. Monitoring in Clinical Use (CUER)

   This course introduces how to evaluate experiences from the clinical use of in-house IVDs and how to systematically collect and assess safety and performance data. Participants will learn to develop and integrate appropriate plans and reports into quality management and take corrective actions when necessary.
   (Available from: November 2025)
   
   

9. Competence in Literature Search

   This course teaches how to conduct systematic literature searches in databases such as PubMed for performance evaluation of lab tests. Participants will learn to qualitatively assess studies and use scientific evidence effectively for validation, verification, and monitoring of LDTs.
   (Available from: February 2026)
   
   

10. Practical Implementation of ISO 5649: Minimum Requirements and Documentation for Laboratories

    This course covers the basics of ISO 5649 for LDTs and highlights the differences from ISO 15189. Participants will learn how to implement a standards-compliant system for safety, performance evaluation, risk management, and documentation in everyday laboratory work with minimal effort.
    (Available from: February 2026)
    
    

11. Statistical Methods for Laboratories

    This course provides practical training in statistical methods for validation, quality control, and accreditation in the lab. Participants will learn to define statistical parameters, analyze and document lab data correctly, and confidently communicate findings in daily operations and audits.
    (Available from: February 2026)
    
    

12. External Quality Controls – Proficiency Testing (EQA)

    This course teaches the implementation and evaluation of external quality control (EQC), including proficiency testing, root cause analysis, and deriving corrective actions. Participants will learn how to implement EQC processes in compliance with regulations, use reference materials correctly, and systematically analyze deviations.
    (Available from: February 2026)

All modules at a glance