ISO 14971:2019 Identifying potential use errors When working with usability engineering and interface design, a very effective and systematic way to help you identify potential use errors is to use the ‘PCA analysis’. The PCA analysis breaks down each use step into three components: Perception, Cognition, and Action, hence the name PCA. Breaking each step […]
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
The basic idea of DoE is that a number of factors, thought to impact a number of outputs, are systematically varied at different levels.
The magazine focuses on the development of the ecosystem as well as on selected strengths that in the future can and will characterize our healthcare system in a global perspective.
You have an idea for a new product. It is actually great and you think to yourself: ‘If I find this useful surely others will, too. People even say they can’t wait to get their hands on it.
Technolution’s design control specialists can quickly gain an overview of the product and the project to ensure a red thread during the design control documentation process.
To avoid half-peeled potatoes, we have collected a checklist that you can use to ensure that your system requirements are not misinterpreted.
ISO 14971:2019 The highlights of the updated risk management standard Terminology update, most noticeably the definitions: Benefit: Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health. State of the art: Developed stage of technical capability at […]
increase the quality and safety Implementing an effective Risk Management process Identifying, estimating, and evaluating your device risks at the right time will increase the quality and safety of the device and can motivate the project members. Furthermore, it adds value by decreasing the project risks and avoiding costly late-stage changes. An effective Risk Management […]
Philips Healthcare IntelliSave AX700 An anesthesia workstation Philips Healthcare needed the right resources for the implementation of the risk analysis of a new complex device – an anesthesia workstation containing mechanics, electronics and software. Procedures and practices were to be updated according to current standards (ISO 14971). Technolution has contributed with know-how to new processes and has thereby […]