Medical Device Development Services In USA
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Manufactured by Resoneticsbased in USA
Minimally invasive therapeutic and diagnostic medical products for: Electrophysiology cardiology, radiology, cryotherapy, drug delivery, pulmonology, gastroenterology, pain management, neurology. Catheter-orientated manufacturing process development. Supply chain selection, management, and technical oversight. In-vivo study protocol ...
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based in 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 ...
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based in USA
At in2being, we specialize in helping both businesses and individuals navigate medical device development and design within the regulatory landscape in the most efficient way possible. in2being’s skilled med-tech professionals are the catalyst that brings customer ideas to life while achieving clearance through the FDA ...
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by Orthogonalbased in USA
Drastically Reduce Time to Market & Adapt to Change Faster Than Your Competitors. Orthogonal applies Agile software development methods to medical device software development, allowing us to move faster while still delivering the quality, safety and reliability your device ...
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by STEMartbased in 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- ...
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by STEMartbased in USA
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. ...
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based in USA
DIAGNOSTIC PLATFORM EXPERTISE: Instrument design; Consumables design; Detection; Imaging; Fluidics; Surface modification; Sensing; Thermal control; Precision motion control; Precision dispensing; ...
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based in USA
Device Types: On-body injectors; Autoinjectors; Pen injectors; Prefilled syringes; Insulin pumps; Microneedle array devices; Smart pills; Electroporation-enabled ...
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based in USA
Device Types: Ambulatory Insulin Pumps; Patch Pumps; Smart Pens & Pen Caps; CGM Systems; Mobile Apps; Automated Insulin Delivery (AID) ...
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by STEMartbased in 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 ...
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by STEMartbased in 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 ...
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by STEMartbased in 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. ...
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by STEMartbased in 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. ...
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by STEMartbased in 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 ...
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by STEMartbased in 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 ...
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based in USA
The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new medical ...
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Manufactured by Foster Corporationbased in USA
Foster founded the Medical Plastics Innovation Center within our Putnam, CT facility. The Innovation Center includes a wide range of equipment for comprehensive support of medical device development programs. At the center of the facility is twin screw extrusion for blending and compounding new medical polymer ...
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Manufactured by MediPurposebased in USA
The MediPurpose™ Medical Device Innovation division collaborates with medical device inventors and innovators to take new medical devices from concept to commercialization—bringing together financing, proven medical device development ...
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Manufactured by Cambrex Corporationbased in USA
At Cambrex, we’re equipped to analyze raw materials to support pharmaceutical and medical device product development and manufacturing. ...
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Manufactured by EirMed - Trelleborg Healthcare & Medicalbased in USA
In conjunction with EirMed’s finishing and assembly services, we offer customized device packaging. Each packaging solution is selected to ensure safe and cost effective delivery of your medical devices. EirMed has developed partnerships with sterilization companies to ensure all sterilization requirements are met. Offering ...
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