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Iso 13485 Software Vendor Serving USA
28 companies found
Software vendorbased inMilan, ITALY
Newronika restores brain and body functions with innovative technologies. We translate our deep knowledge on biosignal decoding into clinical practice, with the aim of improving treatments, health, and wellness. With our revolutionary brain devices, ...
Newronika Quality Management System ensures proper implementation and effective monitoring of design, development, purchasing, production, marketing, customer communication, and assistance processes. The implementation and maintenance of the Quality ...
Software vendorbased inLa Canada, CALIFORNIA (USA)
AQA Company develops document control and quality management software for small to medium size companies. In 2008 ISOXpress software was launched to assist in managing and controlling the ISO 9001, ISO 13485 and ISO 14001 standards. In January 2016 ...
Software vendorbased inRochester, NEW YORK (USA)
With a focus on vendor agnostic integration and service, ayData is a worldwide provider of NDT solutions for indexed archiving and sharing DICONDE images and information that improve workplace efficiency and drive down costs. ayData works with other ...
Software vendorbased inBudapest, HUNGARY
Kinepict Health Ltd. was founded in 2015 and rose as a result of 20+ years of research. So far our team has completed several clinical studies validating our patented Digital Variance Angiography (DVA) technology, published peer-reviewed papers in ...
Software vendorbased inVienna, AUSTRIA
SK-Telemed GmbH is a complete system integrator for IT solutions in healthcare business processes. Collaboration with industry leaders in software and hardware, high competence of our team, successful experience of implemented projects and stable ...
Software vendorbased inBernex, SWITZERLAND
Pixmeo SARL, founded by the original creators of OsiriX, specializes in the development of medical imaging software and providing PACS installation and support services. Located in the Geneva area of Switzerland, the company is ISO 13485 certified, ...
Software vendorbased inAtlanta, GEORGIA (US) (USA)
Sequenex is at the forefront of medtech software development, providing expertise in Software as a Medical Device (SaMD) and digital health solutions. Their offerings include prebuilt platforms like NEX that allow rapid deployment and significant ...
Software vendorbased inSalt Lake City, UTAH (USA)
Everything we do is designed to help you develop, manufacture and commercialize products that help people live longer, healthier and more enjoyable lives. Being a global leader starts with a commitment to being local. MasterControl has deep ...
Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing. By utilizing this software, companies can effectively address the complexity of change control ...
Software vendorbased inSchwerte, GERMANY
Fleischhacker GmbH & Co. KG, headquartered in Schwerte, is a trading company for medical and laboratory technology with many years of experience in the international aid business. In Germany, we mainly supply hospitals, general practitioners, ...
Software vendorbased inHamilton, NEW JERSEY (USA)
Honeywell, a global industry leader recognized for its commitment to excellence, proudly introduces an expanded portfolio of cutting-edge solutions that redefine quality management and the digital future for life sciences and other regulated ...
Medical device manufacturers must comply with 21 CFR Part 820, medical device reporting (MDR), premarket notification 510-(k), investigational device exemption, and quality system (QS) regulations. Audits help manufacturers to improve quality, ...
Software vendorbased inKarlsruhe, GERMANY
medavis GmbH is an owner-managed, medium- sized company that has been a specialist for process optimization in radiology for 25 years. By concentrating on this core competence, many years of experience and sophisticated interface technology, the ...
Software vendorbased inAlbuquerque, NEW MEXICO (USA)
Indica Labs is the world’s leading provider of computational pathology software and services. Our flagship HALO image analysis platform enables fast, quantitative evaluation of tissues using a broad range of artificial intelligence (AI) and computer ...
HALO Prostate AI, from Indica Labs, is a CE-IVD certified deep learning based screening tool designed to assist pathologists in the identification and grading of prostate cancer in core needle biopsies. The algorithm automatically analyzes all ...
Software vendorbased inToronto, ONTARIO (CANADA)
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. Our pedigree is as a medical device research company creating new medical technology related to heart health since 1998. We have offices in both North ...
Forget all those repetitive and time-consuming tasks and small processes that end up taking an unreasonable amount of time and energy. qmsWrapper now provides Custom Issue Forms as a new driving force of your workflow. Now you can make a custom web ...
Software vendorbased inTucson, ARIZONA (USA)
Clinisys is a global provider of intelligent diagnostic, laboratory informatics solutions designed to redefine the modern laboratory, across healthcare, life sciences, environmental, water/wastewater, and public health. Millions of diagnostic ...
Vein-to-vein blood transfusion management improving patient safety. Clinisys Blood Bank Management is a comprehensive and fully compliant Blood Bank solution with multi-facility inventory control, automation, and patient safety measures. Our ...
Software vendorbased inBoston, MASSACHUSETTS (USA)
At PathAI, we’re dedicated to improving patient outcomes with reliable AI-Powered technology and meaningful collaboration with biopharma, laboratories, and clinicians — aiming to provide patients with access to accurate diagnoses and effective ...
Software vendorbased inTampa, FLORIDA (USA)
Qualityze is a cloud-based technology solution provider for Enterprise Quality Management System (QMS). We offer a comprehensive portfolio of high-quality, scalable, flexible, secure technology solutions for the critical quality process such as: ...
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory requirements are increasingly stringent throughout every step of a product’s life ...
Software vendorbased inTampa, FLORIDA (USA)
CQ, an enterprise quality and safety management system (EQMS+EHS), helps manufacturers and suppliers. Significantly improve an organization’s culture, collaboration, competency, efficiency, performance and innovation through the digital ...
Software vendorbased inGivatayim, ISRAEL
Founded in 2005, Orcanos Software has built its reputation on delivering integrated solutions that ease the time-to-market product hurdles that are part of the Quality Journey. In fact, Orcanos is the only vendor that provides an integrated software ...
Adhere to strict MDR/FDA regulations and ISO quality standards by eliminating paper-based QMS ...
Software vendorbased inSan Jose, CALIFORNIA (USA)
BrightInsight provides the leading global regulated digital health platform for biopharma and medtech. Our medical-grade Internet of Things (IoT) platform is built under a Quality Management System to support and optimize regulated drugs, devices ...
The leading global regulated Digital Health platform for biopharma and ...
Software vendorbased inToronto, ONTARIO (CANADA)
Cority gives every employee from the field to the boardroom the power to make a difference, reducing risks and creating a safer, healthier, and more sustainable world. As EHS and sustainability experts, we know what you’re facing, and we’re ...
