The demand for medical device software continues to grow and there is an associated increase in its importance and complexity. This paper discusses medical device software process assessment and improvement. It outlines Medi SPICE, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device d...

BACKGROUND Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. METHODS AND FINDINGS We performed a systematic review to find empirical studies evalu...

Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD...

electing the most appropriate plastic material for a medical device is no easy task. Designers must balance cost-containment pressures that favor using the least-expensive material and S processing techniques against the need to ensure the patients’ safety and wellbeing at any cost. Product liability also is a concern. So for any given application, the designer ends up specifying the most affor...

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IE...

background patient safety is one of the major issues which are concerned with the world health organization (who) and the medical community in developing and developed countries. based on studies, about 10 % of patients admitted in hospitals will be damaged. objectives the aim of this study was to evaluate patient safety climate among nurses and their roles for predicting medical errors. patien...

To examine how patient safety considerations are incorporated into medical device purchasing decisions, individuals involved in recent infusion pump purchasing decisions at three different health care organizations were interviewed using a structured interview process. Interview questions covered triggers for the purchasing process; the purchasing process itself; how safety was evaluated and in...