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Medical Devices Services In Usa California
50 services found
by:Proregulations based inSanta Clara, CALIFORNIA (USA)
FDA Medical Device Registration: A medical device is difficult to classify since new technology and intended use, our regulatory consulting can help you to classify and determine the device in the united states, and we can process with your submission with FDA. Prepare the correct FDA submission and proper U.S. ...
by:Proregulations based inSanta Clara, CALIFORNIA (USA)
Medical device packaging testing is to verify and test the performance of packaging in a laboratory. Registration data for medical and medical products are required to include the results of packaging studies to demonstrate the safety and effectiveness of the contents after delivery, transportation, storage and until ...
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:Anresco Laboratories based inSan Francisco, CALIFORNIA (USA)
Anresco Laboratories now offers medical device testing services to assess the conformity of personal protective equipment (PPE) to required specifications. Services offered ...
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 and regulatory submissions. Our ...
Manufactured by:Rock West Solutions based inGoleta, CALIFORNIA (USA)
As the world of technology explodes around us, it may seem surprising that the technology used by medical professionals is often outdated. As one of the wealthiest nations in the world, there is no excuse for this lack of innovation. We can help to rectify this situation by improving the level of technology doctors, clinics, and hospitals have at their disposal. We have come to understand 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 ...
by:Life Science Outsourcing, Inc. based inBrea, CALIFORNIA (USA)
Life Science Outsourcing offers turnkey medical device manufacturing and assembly services that can be combined with our engineering and process development solutions to create a streamlined and comprehensive process. ...
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 ...
Manufactured by:A-Laser Precision Laser Cutting based inMilpitas, CALIFORNIA (USA)
The medical industry presents unique challenges to precision parts manufacturers. Not only are the applications cutting edge, but demanding in terms of traceability, cleanliness, and repeatability. A-Laser has the equipment, experience, and systems in place to provide our customers with the highest quality products in the most reliable and efficient manner possible. A-Laser ...
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 ...
by:Proregulations based inSanta Clara, CALIFORNIA (USA)
U.S. FDA Medical Device Establishment Registration and Listing: DA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer of medical device must register and list the device. However, except for initial importer do not need to register but ...
by:NSAI Inc. based inNashua, NEW HAMPSHIRE (USA)
ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
As competition and increased regulation drive innovation, collaboration between partnerships in a global environment becomes critical to the success of medical device commercialization. We provide pharma and biopharma leaders with insights to reduce regulatory risk and remain compliant, while evaluating strategic tasks against proven strategies that can help ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
ZebraSci’s experience in primary container engineering, human factors, and medical device commercialization for auto-injectors, needle safety devices and novel drug-device systems assists organizations in developing combination products – from early concept through commercial launch and post-market ...
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 ...
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 ...
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: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) ...