Using task analysis to identify potential use errors and get valuable design input

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 […]

Design Control as a discipline

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.

The highlights of the updated risk management standard

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 […]

Implementing an effective Risk Management process

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 […]