China
Africa
Explore chapters and articles related to this topic
Regulatory Affairs (SOP-11)
Published in Ilkka Juuso, Developing an ISO 13485–Certified Quality Management System, 2022
The choice of what you include in your product labeling is affected by the regulations. The crucial bit to understand here is that labeling is a broad term that applies to more than just the label stickers on your device; it refers to all labels and manuals you expect your user to see. In particular, this means the shield label and the instructions for use (IFU) but also the user interface labels in your product. Thus, also standards like IEC 62366–1 on the application of usability engineering to medical devices and the IEC 60601 series of standards on medical electrical equipment may come into play and may affect your product realization and risk management activities.
Using Design Thinking to Develop a New Product
Published in Kaushik Kumar, Muralidhar Kurni, Design Thinking, 2023
Blaž Zupan, Vladimir Pakrac, Anja Svetina Nabergoj
Once the product is defined in terms of design and function, it is also ready for the laboratory and safety tests carried out by the notified body. The latter is responsible for verifying that the product is safe and suitable for use in critical industries such as medicine. The fact that legislation requires usability tests is proof that usability is not a design “myth” but a real feature of the device that in principle costs the company nothing, apart from the time it invests in finding the best possible functionality for the device. This is defined by the IEC 62366–1:2015 Medical devices—Part 1: Application of usability engineering to medical devices.
Prerequisites
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
FDA published a guidance document25 on human factors and usability engineering. In most other jurisdictions, the IEC 62366–1 (Medical devices—Part 1: Application of usability engineering to medical devices.) standard is used. FDA guidance and IEC 62366–1 standard mandate that the manufacturer needs to apply a systematic process to analyze, specify, develop, and evaluate a medical device’s usability related to safety.
Usability engineering in practice: developing an intervention for post-stroke therapy during a global pandemic
Published in Journal of Medical Engineering & Technology, 2022
Avril D. McCarthy, Louise Moody, Mark L. Reeves, T. Jamie Healey, Tim Good, Lise Sproson, Adewale Adebajo, Wendy Tindale, Krishnan Padmakumari Sivaraman Nair
Table 1 outlines some of the UK, European and International standards and recommendations relating to medical devices, risk management, electrical safety and human factors engineering – areas that are commonly intertwined in ensuring safe and acceptable device usability. Within Table 1 the ISO 14971 standard [8] relates to risk management and this should be applied during the life cycle of all forms of medical device. Depending on whether the device is electrically powered and/or employs software, will also influence the selection and use of other specific standards highlighted in Table 1 such as the IEC 60601 family for medical electrical equipment or IEC 62304 [11] for medical device software. IEC 62366 [10] relates specifically to medical device usability during normal usage. However, IEC 60601-1-6 [12], which also focuses on usability, may be more appropriate to employ when developing electrical medical devices. The context of usage is also important, and within the 60601 family is 60601-1-11 [13], which focuses on intended medical device use in the home environment. Again referenced in Table 1, the UK’s medical device regulator (the MHRA), the European Commission and the American National Standards Institute (ANSI) have provided guidance, recommendations and updated medical device regulations centring on usability engineering and human factors. Thus reflecting the importance of achieving effective usability to reduce user risk and deliver safe devices able to meet regulatory compliance requirements.
An equipment qualification framework for healthcare
Published in IISE Transactions on Healthcare Systems Engineering, 2020
Dermot Hale, Enda F. Fallon, Christine FitzGerald
Human Factors Engineering: Human Factors Engineering (HFE) can be considered primarily through standards and tools for assessing usability of medical equipment in the use environment, in particular in the development and execution of summative usability tests. IEC 62366: Medical Devices – Application of Usability Engineering to Medical Devices is a process-based standard that specifies a process for medical device manufacturers to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device. Table 1 presents a summary of HFE techniques described in IEC 62366.