Software
Medical Devices Come Home
Some in-home medical devices and their gateways communicate directly with the patient to offer help and feedback. Other gateways are designed to be passive and effectively invisible. As the population ages and the number of people requiring medical treatment rapidly...
Caution: V&V May Be Hazardous to Software Quality
Andrew Dallas With the continued uncertainty regarding how much additional information FDA will ultimately require for the 510(k) and PMA application processes, some companies are responding by dramatically increasing the level of detail and the volume of their technical...
10 Steps to Managing Master Data for Devices
Product recalls are an unfortunate yet very real aspect of doing business in the medical device industry. In the years ahead, it is likely that manufacturers will come under pressure to exercise increasing levels of vigilance in recalling devices and products. More recently, there...
Selecting and Using a Manufacturing Execution System
  SOFTWARE       All medical device manufacturers share a common goal: quality. By relentlessly pursuing this goal, device manufacturers seek to satisfy existing customers and win new ones, while avoiding the costly and reputation-sullying consequences of...
Software Seeks Out Heart Attack Risk
  R&D DIGEST   University of Houston professor Ioannis Kakadiaris (right) and PhD student Sean O'Malley examine intravascular ultrasound data recorded in a coronary artery of a patient suffering from atherosclerosis. The original recording is analyzed in...
The Goldilocks Principle: Approaches to Software Validation
SOFTWARE Software is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and to what degree they should validate software systems that are used...
Validating Software for Manufacturing Processes
SOFTWARE Illustration by EYEWIRE Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical device. Perhaps not as widely...
Using Customer Relations to Gain a Competitive Edge
NewsTrends John Zimmer says improved customer relations also helped improve Toshiba's market share. Customer relations can be as important as innovation or research and development. Although there are a few medical devices that don't face competition, most do, and...
Using Simulation to Improve Drug-Delivery Devices
SOFTWARE Understanding and visualizing drug distribution and transport effects in the human body as a whole is important to both medical device and drug manufacturers. This is particularly true in the case of innovative delivery methods such as stent-based or diffusive-patch...
Device Makers Access Key Data from a Distance
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI October 2005 Software Device Makers Access Key Data from a Distance Monitoring software lets manufacturers tap off-site sources of process and product information remotely. By...