Our interdisciplinary team combines expert knowledge in the psychology of learning with industry-leading knowledge in the specification, design, and validation of medical devices and combination products.
All of our training courses are specifically designed to meet the evolving needs of design and development teams in MedTech and Pharma companies. To guarantee training effectiveness and optimize training duration, we tailor the scope and content of each training course to individual skill levels.
We offer specialized training courses across the entire range of our expert services, with different training formats to best meet your unique needs. Choose between presentations or workshops, either in-person or online.
Human factors (HF) / Usability engineering (UE)
Introduction to HF / UE
Implementing a compliant HF / UE process helps you develop innovative, safe, and approvable solutions that are effective, easy to use, and receive wide user acceptance.
HF / UE strategy development
A well-defined HF / UE strategy is essential for the efficient and effective completion of activities and deliverables and requires a profound understanding of factors that will influence your strategy.
HF / UE process implementation
A compliant HF / UE process that facilitates efficient and effective completion of the required activities and deliverables necessitates a thorough understanding of the interdependencies between the HF / UE process and adjacent design and development processes.
Use-related risk management
Known use problems analysis (KUPA)
Completing a known use problems analysis (KUPA) thoroughly and early within the design and development process helps prevent resource-intensive design changes. The analysis also supports the first-time-right selection of the most suitable technology and required risk control measures.
Establishing effective and compliant use-risk controls
Understanding how to interpret and process use-related data throughout the product life cycle is essential for establishing effective risk controls and regulatory compliance.
Formative and summative evaluation
Completion of formative and summative studies
Understanding the different types, methods, and setups for performing formative and summative evaluations so you can choose the most suitable and cost-effective options for your projects.
Expert reviews are powerful, inexpensive tools for identifying potential use problems and risk management opportunities. Understanding the different types, methods, and setups allows you to systematically accelerate your project timelines while saving costs.
Software validation / Computerized systems validation
Introduction to SVAL and CSV
Depending on your business area, the level of customization, and the development approach of your software, different process steps must be followed and deliverables created during validation in order to be compliant with regulatory requirements. This presentation will introduce you to the topic of SVAL and CSV, and how they relate to regulatory requirements, as well as how they can be tailored towards different software development approaches.
Introduction to functional risk assessment
Functional risk assessment is vital in order to identify areas of high risk — both in the system itself and the applied (business) use of the software. It can also be used to tailor testing efforts, test critical functions accurately, and avoid unnecessary expenditures on testing less-than-critical functions.
Introduction to software testing
Software testing consists of several levels, from code review to user acceptance testing. Depending on the risk associated with the use of the software, testing can be approached more or less strictly. This presentation will introduce you to the different levels of testing, as well as the risk-based rationales for what to test (and how much).
Introduction to user acceptance test case writing and execution
How to write a software test that covers both your business processes and the software’s functionality used to support that process. This workshop will explain how to execute tests and document test results.
User interface design
Designing effective instructions for use
Effective instructions for use (IFU) design is based on a thorough understanding of the use-related hazards and hazardous situations combined with systematic consideration of human perception and information processing principles.