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Medical Device Development Services Available In In Usa
65 services found
Manufactured by:Resonetics based inNashua, NEW HAMPSHIRE (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 development, execution, reporting. Clinical site initiation, ...
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:in2being, LLC based inSaline, MICHIGAN (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 ...
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: On-body injectors; Autoinjectors; Pen injectors; Prefilled syringes; Insulin pumps; Microneedle array devices; Smart pills; Electroporation-enabled ...
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: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: Ambulatory Insulin Pumps; Patch Pumps; Smart Pens & Pen Caps; CGM Systems; Mobile Apps; Automated Insulin Delivery (AID) ...
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)
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)
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 ...
Manufactured by:MPE Inc. based inMilwaukee, WISCONSIN (USA)
Unify the medical device development process. Develop successful products without missing vital steps on your way to market. MPE Inc. ensures efficient, focused development by managing evolving insights and requirements. We help you design and develop the product to exact specifications and ...
by:in2being, LLC based inSaline, MICHIGAN (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 ...
Manufactured by:NextPhase Medical Devices LLC. based inMansfield, MYANMAR
NextPhase has developed a strong, team-oriented, multidisciplinary engineering group. Our engineers average more than a dozen years of experience in the medical device development and manufacturing arena. ...
Manufactured by:Foster Corporation based inPutnam, CONNECTICUT (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 ...
Manufactured by:MediPurpose based inDuluth, GEORGIA (US) (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 ...
Manufactured by:Norgen Biotek Corp. based inThorold, ONTARIO (CANADA)
Norgen Biotek is accredited to ISO 15189:2012, emphasizing our commitment to quality in our laboratory and R&D services. Norgen offers a number of laboratory services to the scientific community and for medical device developers and manufacturers including highly competent molecular diagnostic testing for both research purposes and clinical ...