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Development In Medical Devices Services In North America
53 services found
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)
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:Sequenex based inAtlanta, GEORGIA (US) (USA)
Full-service design and development of medical device and digital health software solutions with an emphasis on traceability, regulatory compliance, and rapid ...
Manufactured by:DemeTECH Corporation based inMiami Lakes, FLORIDA (USA)
DemeTech’ s R&D Department will design, develop, prototype medical device ideas. After testing and proof of concept, we can develop final production models and provide scalability for mass ...
Manufactured by:US Medical Innovations, LLC based inTakoma Park,, MARYLAND (USA)
At PMLS, innovation has been the focal point of our business since the company’s founding. To date, developing new medical devices and applications has been our core objective and day after day, we invent new plasma technologies that are helping revolutionize the field of medicine. In doing so, PMLS makes an important contribution to the ...
Manufactured by:Medisurge based inGrand Rapids, MICHIGAN (USA)
Our experienced team can help you develop a medical device from scratch or finish off a project. We can jump in at any of the following stages: Prototyping. If you can imagine it, we can help you bring your vision to life. Engineering. We create high-quality medical devices at a cost that makes sense. ...
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:Microbac Laboratories, Inc. based inPittsburgh, PENNSYLVANIA (USA)
Microbac understands the new challenges facing biomedical companies as the industry undergoes rapid change and the introduction of radical new device designs, biomaterials, and testing techniques. Our staff focuses on working with you to develop a medic device testing regime that will assist in turning your prototype products ...
Manufactured by:Katsan Medical Devices based inIzmir, TURKEY
Today, in the century when all of the processes in business environment have become global, it is important to be able to meet each demand of our customers with a different variety of products and services. At Katsan’s production facilities, we are proud to provide our partners with one of the most sought-after types of services in the world – OEM production. By this way, our ...
Manufactured by:EirMed - Trelleborg Healthcare & Medical based inMenomonie, WISCONSIN (USA)
In conjunction with EirMed’s finishing and assembly services, we offer customized device packaging. Each packaging solution is selected to ensure safe and cost effective delivery of your medical devices. EirMed has developed partnerships with sterilization companies to ensure all sterilization requirements are met. Offering ...
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:ProPlate, operated by Professional Plating Inc. based inAnoka, MINNESOTA (USA)
ProPlate’s dedicated new product development team supports new medical device projects from concept through commericialization through our proven process roadmap. ProPlate® has a library of solutions for a wide range of parts and industries. We are always pleased to take on new challenging projects and expand our Rhodium Plating ...
Manufactured by:Medical Instrument Development Laboratories, Inc. (MID) based inSan Leandro, CALIFORNIA (USA)
MID Labs' Research and Development capabilities include: ...
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. ...
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 ...
Manufactured by:Syncro Medical based inLanghorne, PENNSYLVANIA (USA)
Today’s medical device users demand an experience that is intuitive, attractive, and responsive. For many companies, an excellent UX is the defining advantage over competitive products. Depending on your project needs, Syncro Medical’s engineers can step in at any stage in the design process. With our flexible and tailored ...
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: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:Legend Technical Services, Inc. based inPhoenix, ARIZONA (USA)
LEGEND"s Investigative Chemistry Department specializes in supporting the unique analytical chemistry and physical testing needs associated with medical device manufacturing and product development. Experienced chemists manage routine quality control analyses as well as customized developemental and validation study procedures. Comprehensive ...
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 ...