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Iso 13485 Software Vendor
29 companies found
Software vendorbased inSan Francisco, CALIFORNIA (USA)
We are a fully remote company that helps teams building life-saving products get to market quickly and scale successfully. Our team of Qualians is currently distributed across the world, and we proudly represent different lifestyles, backgrounds, ...
Software vendorbased inHeidelberg, GERMANY
Molecular Health is an international biotech IT company based in Heidelberg, Germany, that has been developing innovative software in the areas of in silico and precision medicine since 2004. Molecular Health’s solutions make it possible to ...
Use worldwide knowledge to reliably determine the risk of genetic disease. MH Guide/Mendel is optimized for the evaluation of germline variants associated with hereditary diseases. The software application is a module of MH Guide and supports human ...
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 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 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 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 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 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 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 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 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 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 inCoralville, IOWA (USA)
VIDA is a precision lung health company, accelerating therapies to patients through AI-powered lung intelligence. VIDA Discovery services enable more efficient respiratory clinical trials by providing more precise quantitative endpoints, AI-powered ...
VIDA provides quality, quantitative CT imaging analysis for all major lung and respiratory diseases to streamline clinical trials with leading ...
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 inRochester, MINNESOTA (USA)
Ambient’s healthcare data visualization solution changes the way providers operate by providing operational and clinical efficiency. This Minnesota-based company in Rochester delivers healthcare data visualization and surveillance tools to hospitals ...
AWARE reduces information overload by filtering for relevant patient data and providing best care practices for improved patient outcomes. The AWARE™ software platform has achieved FDA Class II clearance, CE Marking, and ISO ...
Software vendorbased inHouston, TEXAS (USA)
Quality Institute of America, established in 1994 in Houston, Texas, aims to enhance client profitability through efficient Management Systems. It has expanded across two continents, offering consulting, training, and auditing services. The firm ...
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 inDarmstadt, GERMANY
The development and support of our software solutions is carried out exclusively in Germany by qualified BAYOOMED employees. This allows us to personally accompany and advise you on your project right from the start. You tell us your vision and we ...
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 ...
