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Medical Receives Breakthrough Device Designation Services In Usa
24 services found
Manufactured by:EirMed - Trelleborg Healthcare & Medical based inMenomonie, WISCONSIN (USA)
EirMed develops a tool prototype as soon as our team of engineers, manufacturers and the client agree on the tool’s design. Tool prototyping is the next step of the design and engineering process before full-scale manufacturing begins. By prototyping and testing the tool, we get an accurate depiction of the tool’s capabilities along with what the finished part would look like. This ...
Manufactured by:BMP Medical based inSterling, MASSACHUSETTS (USA)
BMP Medical has the ability to consult with our customers on both the design of their parts and the design of their tooling. We partner with local vendors to provide medical device design consultation from concept to final product. Often times, we offer advice and assistance when the mold and part design does not lend itself to a product that is easily molded. Our engineers can step in ...
Manufactured by:Ginolis Ltd based inOulunsalo, FINLAND
Ginolis provides design support to ensure that medical device and diagnostic designs are automation ready. The ability to identify and correct downstream issues will lead to reduced cycle time, higher product quality, and lower development and manufacturing costs. ...
Manufactured by:Atrion Medical based inArab, ALABAMA (USA)
Operational excellence is the standard. All of our products are MADE IN THE USA. We take a scientific approach to Manufacturing, utilizing vision, robotics, automation and advanced fixturing to ensure every component, in every device, meets our strict quality requirements. Our talented team of operators, technicians and engineers brings it all together to meet our customers’ ...
Manufactured by:Myriad Fiber Imaging Tech Inc. based inDudley, MASSACHUSETTS (USA)
The team at Myriad brings extensive expertise in the design, development, and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support the regulatory filing process. Myriad has supported the Research & Development community for years by providing assemblies and sub-assemblies designed for production. We work closely with large Med ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
At Lighthouse Imaging, we work with our OEM partners to create solutions for their end customers that meet their demands and chalenging work environments. Visualization is the primary link between a surgeon and their work. This interface must be seamless and immersive, which is why our holistic optical design approach enables our clients to deliver medical devices of the highest ...
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 medical device regulation process and other regulatory bodies. ...
by:Orthogonal based inChicago, ILLINOIS (USA)
A Design Process Informed By Fast Feedback, Successful SaMD must achieve a delightful and safe user experience. Our design process is aligned to achieve both by engaging iterative user feedback throughout the product ideation and design ...
by:Exact Metrology based inBlue Ash, OHIO (USA)
Reverse Engineering is oftentimes a catch-all term used for Design & Engineering applications. But trust us, there is so much more to this category for the uses of our 3D scanners, portable CMMs and laser trackers. Also, reverse engineering tends to imply that the 3D scanning will be used solely for product design, when in fact it can be used to address many other engineering functions ...
Manufactured by:Nordson Medical based inHuntington Beach, CALIFORNIA (USA)
Nordson MEDICAL provides elegant and robust design and development solutions of finished medical ...
Manufactured by:Resonetics based inNashua, NEW HAMPSHIRE (USA)
Medical device conceptual design and evaluations. Complex part design (Solidworks). Complete catheter delivery systems. Handle and mechanism design. Nitinol implants and delivery system componentry. Drawing package development and design documentation. Product and component sourcing to find the best solution, utilizing both the broad manufacturing capabilities across the Resonetics network and ...
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 ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
Lighthouse Imaging optical image processing design and services that meet the demands for the next general medical devices. By working with Lighthouse from the onset of a optical imaging project, and not just from when a product is “deemed ready,” OEM clients can reduce the timeline for commercialization as they are developing a product for manufacturing, not just a product to meet ...
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 ...
Manufactured by:MMT Inc. based inCharlotte, ALABAMA (USA)
At MMT we offer a host of medical manufacturing services, including device assembly ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
Lighthouse utilizes the phase/gate process that takes optical medical devices from concept through commercialization. We understand the importance of design control and risk management activities and incorporate these into our rigorous product development process. Lighthouse utilizes a traditional phase/gate process that takes medical devices from concept through commercialization. We understand ...
Manufactured by:Noxilizer, Inc based inHanover, MARYLAND (USA)
Noxilizer’s expert in-house microbiology and materials science team will work with you to perform sterilization testing to your requirements. We offer a wide range of testing services that conforms with ISO standards both in-house at our Hanover, MD facility and through external labs. Each customer has a dedicated team working through every step of the ...
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 ...
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 methodology and global experience to help ensure success. Taking a new medical invention from concept to commercialization can be a difficult process, ...
by:V-Wave Ltd. based inCaesarea Industrial Park (N), ISRAEL
Heart failure (HF) is a condition where the heart is not pumping enough blood to meet the needs of the body. When heart failure occurs, there is an increase in pressure in the heart and lungs, plus fluid build-up in the lungs. The fluid causes congestion and makes it hard to breathe during activities or even when at ...