Usability Engineering, Human Factors & Clinical Requirements
Usability Engineering, Human Factors & Clinical Requirements
Improving User Safety, Clinical Evidence, and Regulatory Documentation
Product usability and clinical or performance evaluation are essential components of successful product development.
Our training programs provide a practical understanding of the requirements for usability engineering, human factors, clinical evaluation, and performance studies.
Key Training Topics:
- Usability engineering according to IEC 62366-1
- Integration of human factors into risk management according to ISO 14971
- Formative and summative usability evaluations
- Clinical evaluation and clinical investigations under the MDR
- Medical device clinical investigations according to ISO 14155
- IVD performance evaluation and performance studies under the IVDR and ISO 20916
- Clinical trials of medicinal products under Regulation (EU) No 536/2014
- Good Clinical Practice according to ICH E6(R3)
- Regulatory documentation and assessment of clinical evidence
Value for Your Organization: Better integration of user safety and clinical requirements into product development, together with more effective planning of regulatory evidence.
Customized Training Solutions for Your Organization
Tailored to Your Needs — Not One-Size-Fits-All
Every organization has its own processes, products, capabilities, and regulatory challenges.
That is why we develop our training and workshop programs around your specific requirements.
Whether you want to qualify new employees, strengthen existing expertise, implement regulatory changes, or solve complex quality problems, our training content is tailored to your objectives.
Our Training Formats
In-House Training
Company-specific training programs tailored to your products, processes, and organizational requirements.
Interactive Workshops
Practice-oriented workshops featuring case studies, group exercises, and real challenges from your organization.
Online Training
Flexible virtual training programs for national and international teams.
Individual Coaching
Targeted technical and methodological support for specialists, managers, and business leaders.
Project-Based Training
Direct knowledge transfer within ongoing development, quality, or process improvement projects.
Why Choose Avary Consulting for Your Training Programs?
Transforming Specialized Knowledge into Measurable Improvements
Interdisciplinary Expertise
Combining regulatory requirements, technical processes, quality management, statistics, and project management.
Practice-Oriented Learning
Applying methodologies to realistic scenarios and actual business processes.
Regulatory Relevance
Integrating applicable laws, regulations, standards, and guidance documents into the relevant training topics.
Customized Training Concepts
Adapting content, complexity, and delivery formats to your target audience and organizational objectives.
Sustainable Knowledge Transfer
Focusing on the practical application of acquired knowledge and the long-term development of internal capabilities.
Invest in Your Team’s Expertise
Let’s Develop Your Customized Training Program Together.
Are you preparing your team for new regulatory requirements, looking to improve your CAPA processes, introducing Six Sigma methodologies, or strengthening statistical capabilities in product development and validation?
Avary Consulting supports you in designing and delivering a training program tailored to your organization’s specific challenges.
Request a no-obligation proposal for your training program or workshop.
Email: info@avary-consulting.de
AVARY CONSULTING
Regulatory Excellence. Strategic Solutions. Sustainable Improvement.