Titled "Change Control - Quality Improvement in FDA & ISO Environments," this white paper discusses what FDA inspectors and ISO auditors consider one of the most critical regulatory principles.
Every week, FOI Services adds newly received FDA documents to its online library. One can always see what's new at the FOI Online site and also pick up a complimentary "Document of the Week" by clicking on the "Document of the Week" picture on the home page. Information: www.foiservices.com .
In support of customer 3D modeling needs, Empire Magnetics has recently made available on its website more than 2,000 solid models of various motor and related product combinations.
Gore has added assemblies to its online interactive design guide. The tool now provides a menu of connector options to configure a complete Gore high flex flat cable assembly or Gore trackless cable assembly with ten day lead times.
The third in its Parts Smarts booklet series, UFE introduces “The 9 Plastic Gear Must Ask Questions.” The online booklet answers essential questions for engineers to consider when designing plastic gears.
As physicians, patient groups, and Congress pressure the FDA for stronger monitoring and recall action on devices and diagnostics, a manufacturer’s risk-management program must be stronger than ever.
Steris Isomedix Services has launched the SteriLink Internet-based customer interface, an interactive service that provides complete, real-time visibility into Steris Isomedix’s processing facilities.
Protomold offers fast turnaround on injection molded prototypes, plus the ability to have them shipped even faster for a premium. Now, the ProtoQuote web-based quoting system gives users the ability to explore the effect of different delivery schedules on a quoted price.
The Melt-Disk hot runner system provides simple, versatile horizontal hot tip processing for direct side gating applications. The key to Melt-Disk’s excellent processing performance is the controlled heating element on the disk portion that ensures optimal heat control in the gate area.
The SLH series of high performance size 5 (12.7 mm diameter) small slotless brushless DC motors were specifically designed for powering precision instruments such as surgical hand pieces and similar medical and dental power tools.
This mobile workstation and OR gateway is equipped with a DICOM digital video recorder (DVR) that can augment other manufacturers current OR solutions.
EduNeering, a leader in knowledge solutions for business improvement and regulatory compliance, offers its proprietary Performance and Risk Optimization for Value Enhancement (P•R•O•V•E) solution.
Demand for implantable medical devices will increase over 10% annually to $36.4 billion in 2009. An expanding prevalence of heart, orthopedic, neurological, visual, and urinary disorders coupled with new, high value-added product introductions will promote gains.
The PC-controlled Scepter is optimized for the automated polishing of various medical devices that incorporate fiber optic lightguides. Instruments such as catheters, endoscopes, probes, illumination bundles, image fibers, and laser delivery cables are processed, resulting in scratch-free surfaces.