Many medical device firms receive Form 483 citations from the FDA because of issues related to quality audits, corrective and preventive actions, employee training records, documentation control, etc.
A mechanical engineer at Purdue University is teaming up with medical doctors in research aimed at developing less expensive, portable, and versatile surgical robots that could become more common in operating rooms.
While most companies try to solve healthcare design challenges as they arise, GE Plastics is a company that sees global application technology (GApT) and design as a major competitive advantage as it accelerates expansion of GApT capabilities worldwide.
Medwave Inc.an innovator in sensor-based, non-invasive blood pressure measuring solutionshas selected the Kaon Advisor to showcase the Primo non-invasive blood pressure (NIBP) monitoring system.
In the ongoing movement to establish more wireless options for medical devices, concerns over adequate power sources become a primary issue for manufacturers. This exclusive article will examine Lithium-ion technology and analyze the essential components of the battery pack. By Dr.
The Project: Create an alternative to the inspection protocols that rely on a human operator to verify the quality of electrosurgery electrodes. The Solution: Develop a 100% automated inspection system, that maintains rapid throughput, to ensure consistent results.
The Project : Create a device to enable the high speed digital scanning of slides for use in virtual microscopy. The Solution: Use precision motion control components to ensure extremely high resolutions, that are free of imperfections, are achieved.
The Project: Streamline the document management and retrieval processes to enable a more efficient regulatory compliance protocol. The Solution: Implement an electronic product lifecycle management solution to manage product-related information.
Medical device OEMs can partner with contract manufacturing firms to optimize their supply chains to gain a competitive advantage over other manufacturers in the industry.
A full line of label and barcode printing systems for work in process (WIP) tracking, product identification, component tracking, shipping and logistics, and regulatory labeling applications is available.
Flexible Hytrel style Type 888 hose features injection molded alloy cuffs that are made without adhesives to eliminate potential leakage and odors, and it can be sterilized by ETO gas, radiation, or pasteurization (275°F).
A manufacturer of O 2 concentrators for in-home oxygen therapy wanted a unit that would simultaneously fill portable bottles while supplying the patient.
The 3B23 solenoid valve is designed for medical device applications that require media-separation such as dialysis machines, instrument cleaning devices, and dental irrigation equipment.
The Type 57 Butterfly Valve incorporates four major design upgrades in thermoplastic valve technology. New design features include a flange stopper, which prevents the valve liner from over compression. A second feature is a molded body absorption channel.
The VSO-EP is a module for precision control of critical system pressures. It is an automated alternative to manual pressure regulators, needle valves, flow controllers, and bleed orifices, providing integral closed-loop proportional control for both dynamic and “set and forget” applications.