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Medical Device Development Services In Usa California
17 services found
by:NOVO Engineering based inVista, CALIFORNIA (USA)
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials ...
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)
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. ...
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 ...
by:NOVO Engineering based inVista, CALIFORNIA (USA)
Device Types: Ambulatory Insulin Pumps; Patch Pumps; Smart Pens & Pen Caps; CGM Systems; Mobile Apps; Automated Insulin Delivery (AID) ...
by:NOVO Engineering based inVista, CALIFORNIA (USA)
DIAGNOSTIC PLATFORM EXPERTISE: Instrument design; Consumables design; Detection; Imaging; Fluidics; Surface modification; Sensing; Thermal control; Precision motion control; Precision dispensing; ...
by:NOVO Engineering based inVista, CALIFORNIA (USA)
Device Types: On-body injectors; Autoinjectors; Pen injectors; Prefilled syringes; Insulin pumps; Microneedle array devices; Smart pills; Electroporation-enabled ...
by:STEMart based inShirley, CALIFORNIA (USA)
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. ...
by:STEMart based inShirley, CALIFORNIA (USA)
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. ...
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 ...
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 ...
Manufactured by:Medical Instrument Development Laboratories, Inc. (MID) based inSan Leandro, CALIFORNIA (USA)
MID Labs' Research and Development capabilities include: ...
Manufactured by:Nordson Medical based inHuntington Beach, CALIFORNIA (USA)
Nordson MEDICAL provides elegant and robust design and development solutions of finished medical ...
Manufactured by:Nordson Medical based inHuntington Beach, CALIFORNIA (USA)
We are here to make sure your project starts off at full speed by bringing cross-functional expertise and industry experience to every challenge. Our approach to concept generation can launch an innovative design or kick start a stalled project. Or it can provide technical insights that empower your internal project ...
by:BrightInsight, Inc based inSan Jose, CALIFORNIA (USA)
Leverage our team to develop, configure, or host your next digital health solution. Our digital health subject matter experts, software and quality engineers and UI/UX designers are uniquely trained to develop software with an agile, nimble approach that maintains compliance with privacy, security, regulatory, and quality requirements: Professional digital health ...
Manufactured by:Charles River based inHollister, CALIFORNIA (USA)
From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services and regulatory support to comply with worldwide regulatory restrictions for the nonclinical development of pharmaceuticals, medical devices and animal health products as well as chemicals, ...