Medical devices must perform safely and consistently throughout their intended use. Risk management therefore needs to begin during development rather than being treated as a final-stage compliance exercise. Early...
Bringing a medical device from concept to market requires teams to balance performance, usability, manufacturability and commercial viability with a complex set of regulatory requirements. Compliance must be considered...
The reliance on remote monitoring is growing within modern healthcare. However, clinical decisions are only as reliable as the data on which they are based. If a device produces...
Sterile medical device packaging can sometimes be viewed as the final stage in the product development process. In reality, it is part of the device system itself. Packaging decisions...
Cleanroom manufacturing is commonly used for medical device production, particularly where contamination control is important. Therefore, the question usually revolves around whether the level of environmental control is appropriate...
What is Statistical Analysis in Quality Control? Statistical analysis in quality control is where statistical methods are used to measure, monitor and maintain the overall quality of products. Over...
Chronic conditions, such as diabetes, cardiovascular disease, respiratory illness and long-term mobility issues, all require extended periods of supervision. Wearable devices enable continuous patient monitoring and data generation outside...
Adhesive strength is a key parameter in the performance of medical adhesives, which are used to secure devices and dressings to the skin. These systems must maintain reliable contact...
There are thousands of wound dressings available, each designed to support healing in different types of wounds. While most dressings aim to maintain a moist healing environment, the right choice depends on the...
Medical Adhesive-Related Skin Injury (MARSI) refers to damage caused to the skin by medical adhesives, such as tapes or device attachments. It can occur when adhesives are applied, worn,...
