STEMart services

Cytotoxicity testing is a sensitive method to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. This test is performed on raw materials in the manufacturing process, all medical devices contacting patients, and devices undergoing a sterilization validation. 

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. 

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 long periods of time, they muse comply with strict standards and requirements to ensure the health and safety of patients. 

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. 

Prototyping is the process of creating a rudimentary version of a product for the purpose of visualization and conceptualization. In general, prototypes fall into two broad categories: functional and non-functional. Functional prototypes enable people to get a sense of the basic form and functionality of the product. Non-functional prototypes are used to provide people with a non-digital representation of the product. When it comes to medical device prototyping, a functional prototype is not one that can be used in the market—it is not a final product, but a functioning example that can be used to develop a better version of the final product. 

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 are revealed during the pilot production phase, the medical device may need to be reworked. Reworking a medical device takes more time and more money. This is why customers need to find a medical device company that takes seriously the integrity of this process. 

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 requirements for active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices. In order to place a medical device on the European market, manufacturer must obtain a CE mark. 

Cleaning is defined as removal of soil residues with manual or automated method. It is always the first and necessary step in reprocessing of reusable medical device.