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Medical Device Validation Suppliers In USA
9 companies found
based inSan Jose, CALIFORNIA (USA)
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous ...
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team ...
based inMiami Lakes, FLORIDA (USA)
Biorep is ISO 13485 Certified and FDA Registered. As a full-service development firm, Biorep has an exclusive focus on medical products and over 20 years of experience developing medical devices. Biorep enables advancements in medical technologies ...
Before you can bring a critical medical device to market to help enhance – and save – lives, you need to be certain it’s right and ready. Along with a commitment to absolute quality standards, our ...
based inSterling, MASSACHUSETTS (USA)
BMP Medical is your preferred source for custom OEM injection molded medical devices. We are a privately held company that has been in business for over 40 years. We use state of the art molding techniques and machinery to produce varying sized ...
BMP Medical offers full medical device process validation services for all of our customers. We will work individually with a project manager and your team to develop a ...
based inBethlehem, PENNSYLVANIA (USA)
FOCUS Laboratories will provide services that emphasize a proactive approach to microbiological quality assurance, and quality control. We will have a continued commitment to professionalism, communication and adherence to quality. FOCUS ...
Once the bioburden of the medical device is understood, appropriate parameters can be established for assuring device sterility. Sterility must be verified, and this is typically accomplished by direct immersion of the devices in media and ...
based inBoston, MASSACHUSETTS (USA)
Empatica, an MIT spin-off, is a pioneer in offering continuous, passive, and unobtrusive monitoring for patients with neurological conditions. We build software and algorithms to advance understanding of human behavior through wearable sensors. Our ...
Keeping you connected to your loved ones during emergencies. Embrace2 is the only FDA-cleared wrist-worn wearable in epilepsy. It detects possible convulsive seizures and instantly alerts caregivers, whether they're sleeping next door or are living ...
based inHouston, TEXAS (USA)
At ALS Environmental, we provide a full range of environmental analytical testing services, specializing in the analysis of soil, sediment, water, leachates, dust, air, industrial hygiene, and radiochemistry. Analytical laboratory testing services ...
At ALS our Pharmaceutical Division is a provider of testing services to the Pharmaceutical and Healthcare industries in Australia, Europe and Asia. Committed to exceeding customer expectations we are able to provide high quality solutions across a ...
based inBrea, CALIFORNIA (USA)
Established in 1997, Life Science Outsourcing, Inc. was founded to offer contract manufacturing services to emerging medical device companies. As an FDA-registered and ISO 13485-certified Contract Manufacturing Organization, we focus on assembly, ...
The medical device packaging design, testing, and validation process can be intricate and time-consuming, facing intense regulatory scrutiny and often being the largest cause of FDA recalls. ...
based inIrvine, CALIFORNIA (USA)
ASP is a global leader in infection prevention, dedicated to creating the products, solutions and processes needed by practitioners to protect patients during their most critical moments. We are committed to continuously advancing infection ...
Enhances safety to meet your sterilization needs. STERRAD NX® System with ALLClear® Technology is the compact unit from the STERRAD® Systems platform. It includes two sterilization cycles that can reprocess over 23,000 medical devices ...
based inShirley, CALIFORNIA (USA)
STEMart is an industry-leading eCommerce platform, with an expanded global footprint, we now have a broad portfolio of more than 10,000 products. In the fields of science, technology, and engineering, from the discovery stage towards the ...
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. ...