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Stemart Xprt Industry Services
7 services found
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance ...
by:STEMart based inShirley, CALIFORNIA (USA)
Processes close or equal to those to be used in production. Pilot production is a crucial process for devices that will be tested in clinical trials or pilot markets before transitioning to full-scale production. If the customer’s medical device is successful in a pilot market or clinical trial, it will likely transition to full- scale production. But if the medical device has flaws that ...
by:STEMart based inShirley, CALIFORNIA (USA)
Medical device design is a complex sphere that includes creation and development of effective and life-improving tools and technologies aimed at reducing life risks and helping with medical equipment enhancement. Medical devices design is an important specific of product design, since numerous groundbreaking medical tools, advanced equipment help saving, and improving people’s lives. ...
by:STEMart based inShirley, CALIFORNIA (USA)
Material Testing of implantable medical device is critical to ensure product safety and meeting the standards of the highly regulated medical industry. STEMart offers fast, reliable testing and inspection services for metallic, ceramic, plastic materials used in the manufacture of medical implants. We provide important information that customers need for product qualification, material ...
by:STEMart based inShirley, CALIFORNIA (USA)
Medical devices, including medical implants, in a magnetic resonance imaging (MRI) environment pose risks, such as electromagnetic interactions and radiofrequency heating, to patients. The MRI Safety Testing of implantable medical devices is necessary to ensure the patient's safety, implant performance, and compliance with the regulations. ...
by:STEMart based inShirley, CALIFORNIA (USA)
STEMart performs a variety of testing for partial and total hip joint prostheses to measure how they will withstand different levels of fatigue, compression, torsion, and bending over an extended period of time. ...
by:STEMart based inShirley, CALIFORNIA (USA)
An active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice for diagnostic or therapeutic purposes, and which is intended to remain in place after the procedure. Since AIMDs are engineered to maintain direct contact with the body for ...