Human Factors and Usability (IEC 62366-1:2015)
Usability refers to how effectively, efficiently and satisfactorily a device can be used by its intended users in real-world settings. It’s a critical part of device development, post-market monitoring and regulatory compliance
IEC 62366-1:2015 is the international standard governing usability engineering for medical devices, recognised by the FDA, European Commission, and other global regulators.
Apotech helps you meet these usability requirements, particularly for MDR technical files and post-market surveillance.
Trusted by top-tier teams worldwide
We can support with:
- Usability / Human Factors training
- User needs analysis
- User-centred design (UCD)
- Human factors engineering
- Prototype development and testing
- User interface design
- Instructions for use (IFU)
- Usability engineering reports
Featured case studies
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…