A quality manual is one of the elements of a quality management system (QMS) required by ISO 13485:2016. While it isn’t a lengthy document, the quality manual plays a critical role in ensuring that users can navigate your QMS and quickly find specific documents and...
The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies.
“Quality is everyone’s responsibility.” –W. Edwards Deming Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives are at stake. The implications of quality culture extend beyond operational...
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings. DOHA-1...
Failure mode effects analysis (FMEA) is a popular tool for identifying the possible failures in the design of a product or process. FMEA is an industry-agnostic engineering method that makes it widely applicable to a variety of different situations, including medical...
MEWS and PEWS are structured scoring systems designed to quantify a patient’s risk of deterioration based on routine vital signs such as heart rate, respiratory rate, blood pressure, temperature, and level of consciousness. MEWS is primarily used for adult patients...
In 1980, self-interpretive EKG machines were not quite yet invented. In their place was a system to capture the EKG in real-time and send to a mainframe computer. If you thnk you have it tough today connecting an AD620 to an Arduino, consider what it took to capture...
