Engineering

Human Factors/ Usability - IEC 62366-1:2015

Usability for  in research and development refers to the extent to which a device can be used effectively, efficiently, and satisfactorily by intended users in specific contexts of use. Usability encompasses various aspects of user interaction, including ease of learning, ease of use, efficiency, memorability, error prevention, and user satisfaction. IEC 62366-1:2015 is an international standard that specifically covers the application of usability engineering to  and is the overlapping standard for FDA, the European Commission, and other regulatory bodies. Europe’s IVD regulation (EU DR) is a little less specific about usability requirements, as this is covered largely in part in the General Safety and Performance Requirements.  does include requirements for product validation and usability-related activities, of which must be documented in a manufacturer’s technical file. Additionally, the regulation emphasises the need to collect and evaluate usability data as part of a manufacturer’s post-market monitoring and evaluation process. Apotech can support in the following areas:

• Useability/Human Factors Training
• User Need Analysis
• User-Centered Design (UCD)
• Human Factors Engineering
• Prototype and Testing
• User Interface Design
• Instructions for Use
• Useability Engineering Report

Sterilisation

• ISO 11135

ISO 11135:2014 specifies requirements for the application of ethylene oxide (EO) sterilisation to , ensuring that they are safe and effective for patient use. This standard covers various aspects of the sterilisation process, including the selection of appropriate sterilisation parameters, the validation of sterilisation cycles, and the monitoring of EO residuals.

Apotech can provide expertise in interpreting the standard's requirements, developing robust sterilisation processes, conducting validation studies, and establishing quality management systems to ensure compliance. Additionally, we offer guidance on documentation practices, training programs, and ongoing monitoring to maintain the effectiveness of EO sterilisation processes. By partnering with Apotech, organisations can navigate the complexities of ISO 11135:2014 more efficiently and effectively, ultimately enhancing the safety and quality of your  devices.

• ISO 11137

ISO 11137-3:2017 outlines the criteria for validating and managing radiation sterilization methods for healthcare products, with a specific emphasis on dosimetry considerations. This standard plays a crucial role in ensuring the effectiveness and safety of radiation-based sterilization processes in healthcare settings. Apotech  specialises in ISO 11137-3:2017 and provides comprehensive support in implementing these requirements, including conducting dose audits, establishing appropriate validation protocols, and ensuring compliance with regulatory standards. We can support you to navigate the complexities of radiation sterilisation, enhance product quality assurance, and uphold regulatory compliance effectively.