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Medical Devices Services In Usa Texas
19 services found
by:Emergo by UL based inAustin, TEXAS (USA)
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market ...
by:Chemical Inspection & Regulation Service Limited (CIRS) based inHangzhou, CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. ...
by:Emergo by UL based inAustin, TEXAS (USA)
Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. ...
by:Emergo by UL based inAustin, TEXAS (USA)
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches. With deep expertise in post-market ...
by:Emergo by UL based inAustin, TEXAS (USA)
It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements ...
by:KnightHawk Engineering, Inc. based inHouston, TEXAS (USA)
Our broad experience allows us to provide these services for a wide range of products in the petrochemical, manufacturing, medical devices, automotive, aerospace, offshore, marine and rail market ...
Manufactured by:Atrion Corporation based inAllen, TEXAS (USA)
Atrion provides contract manufacturing services for other major original equipment manufacturers of medical devices. Our facilities are registered with the U. S. Food and Drug Administration. Our comprehensive services, including patent assistance and regulatory support, help our customers take their products from idea to ...
Manufactured by:Genesis Medical Plastics based inCypress, TEXAS (USA)
Genesis offers our specialized extrusion, calendering, injection molding and machining capabilities on a tolling basis to convert customers’ medical polymers into the stock shapes, films and components required for their medical ...
by:BSI Consulting based inHerndon, VIRGINIA (USA)
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
Manufactured by:Genesis Medical Plastics based inCypress, TEXAS (USA)
In addition to machining and injection molding specific components, Genesis can assist medical device manufacturers with assembly, laser marking, industry-compliant packaging and other services for a more efficient supply ...
by:Tietronix Software, Inc. based inHouston, TEXAS (USA)
Tietronix is a leading provider of cutting-edge software products and solutions for mission critical applications. Recognized for its expertise in process automation, medical device software development, and control systems for industries such as aerospace, defense, medical, and renewable energy. Tietronix gains its strength from a combination of ...
by:Tietronix Software, Inc. based inHouston, TEXAS (USA)
Tietronix has the knowledge and tools to accelerate your project technologies. While our expertise is in the medical field, including pharmaceutical, biotechnology, medical devices, and health care administration sectors, we can work in any ...
by:CSA Group based inToronto, ONTARIO (CANADA)
Mitigate the risk of a cyber attack with thorough review and testing of your connected products and systems. Cybercrime damage costs are expected to hit $6 trillion annually by 2021, up from $3 trillion in 2015. IoT devices connect twice as many people that are alive in the world. In 2015, the FBI warned about the dangers of IoT, yet most devices are still ...
Manufactured by:Ceutical Labs based inFlower Mound, TEXAS (USA)
There are several distinct markets that are served by the Analytical Testing Division. They include Pharmaceutical, Nutraceutical, Medical Device, API (Active Pharmaceutical Ingredient), NDI (New Dietary Ingredient) and Post Sterilization Testing. Two of these categories, API and NDI require additional explanation. Their definitions are as follows: API -An API is ...
by:Emergo by UL based inAustin, TEXAS (USA)
For many healthcare innovators, opportunities to grow can outpace their ability to scale. Building capabilities in-house requires time and resources that many firms don’t have in the evolving commercial and regulatory demands of the healthcare ...
Manufactured by:Atrion Corporation based inAllen, TEXAS (USA)
Our engineering team is comprised of highly skilled and multifaceted individuals having the ability to think creatively and convert their novel ideas, concepts, and designs from functional prototypes to finished ...
by:Stress Engineering Services, Inc based inHouston, TEXAS (USA)
At Stress Engineering Services, we provide fully connected product, device, and equipment development solutions. The range of application is very broad and includes healthcare products and facility-related initiatives, pharmaceutical drug delivery products, and supply chain tracking. We offer end-to-end solutions including working with your supply chain. Our technical knowledge combined with ...
Manufactured by:Genesis Medical Plastics based inCypress, TEXAS (USA)
Genesis Medical Plastics’ applications and regulatory experience, technical depth, production versatility and post-production services help expedite customers’ projects effectively at every stage and as requirements may ...
by:ALS Environmental based inHouston, TEXAS (USA)
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 range products, including human and veterinary products, intermediates and raw materials. Testing is conducted according to international standards ...