Software
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 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...
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...
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...
AAMI Clarifies Risk Management for Software
Originally Published MDDI May 2005 NEWSTRENDS Erik Swain FDA and other regulators have stressed the need for risk management a lot in the last few years. Most medical device manufacturers now understand that they must incorporate it into their product design process. Performing...
Bridging the Gap: Medical Device Communication with XML
Originally Published MDDI March 2005 Software Bridging the Gap: Medical Device Communication with XML XML has the potential to make widespread improvements in data management for the medical device and healthcare industries. The only problem is, it's just not there yet....