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Medical Device Software In Usa
66 software items found
by:Click Therapeutics, Inc based inNew York, NEW YORK (USA)
We are a regulated Software as a Medical Device (SaMD)-focused biotechnology company that develops our applications as medical treatments in accordance with all relevant FDA, ISO and IEC ...
by:RegScan - by Enhesa based inWilliamsport, PENNSYLVANIA (USA)
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and ...
by:SiteRocket Labs based inBoston, MASSACHUSETTS (USA)
The challenge: Emovi develops and manufactures the KneeKG system, a medical device that assesses knee motion for patients with impaired movement due to an orthopedic cause. The company wanted to modernize some of its software and develop a cloud-based clinical portal without compromising security or reliability. ...
by:Quality Institute of America - QIA based inHouston, TEXAS (USA)
QIA offers a comprehensive suite of software modules designed for pharmaceutical and medical device companies to efficiently manage their Quality Management Systems. The software allows businesses to initiate tasks following best practice workflows and manage them through alerts and escalations. Modules are capable of automatically generating and storing records, ...
by:AWS Truepower, LLC based inAlbany, NEW YORK (USA)
Discover how our validated, FDA CFR Part 11 compliance training management system helps you comply with evolving FDA Regulations. Keep your workforce up to date. Medical device and pharmaceutical manufacturers trying to keep up with ever-changing regulations have a tough job. Medical technology advances quickly, and with it the need for ...
by:AQA Company, Inc. based inLa Canada, CALIFORNIA (USA)
IMSXpress 14971 Medical Device Risk Management software is a Windows application for implementing Risk Analysis, Risk Evaluation, and Risk Control in strict compliance with the ISO 14971:2012 standard. Risk analysis, risk evaluation, and risk control methodologies strictly follow requirements of ISO 14971 and all recommendations included in ISO 14971 Annex B ...
by:Honeywell | Life Sciences based inHamilton, NEW JERSEY (USA)
Now more than ever, leading companies are striving to centralize their complaint handling processes to reduce risk, comply with best practices, and streamline operations. Sparta's complaint handing solutions can be used for documenting, managing, and following up on customer inquiries and complaints and tracking subsequent actions. The system seamlessly integrates complaints with other quality ...
by:Honeywell | Life Sciences based inHamilton, NEW JERSEY (USA)
The Sparta risk management solution enables companies to link risk management processes to other quality management processes. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria and standards such as ISO 14971. Additionally, it can trigger updates to review the product risk register to have a truly closed-loop process. The solution is fully ...
by:Honeywell | Life Sciences based inHamilton, NEW JERSEY (USA)
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, lower costs, and increase compliance. ...
Manufactured by:AMD Global Telemedicine, Inc. based inChelmsford, MASSACHUSETTS (USA)
The Multipurpose Camera and Scope simplifies clinical telemedicine patient exams and workflow processes. This multi-function camera and medical scope system integrates directly with our AGNES Connect telemedicine platform, delivering a seamlessly integration to capture and stream your medical images to the remote provider. This single device is ...
Manufactured by:AMD Global Telemedicine, Inc. based inChelmsford, MASSACHUSETTS (USA)
The Intraoral Dental Camera is a high powered digital camera used in the evaluation of patients’ oral health during healthcare assessments, and part of the AMD Global Telemedicine family of telehealth products and ...
Manufactured by:AMD Global Telemedicine, Inc. based inChelmsford, MASSACHUSETTS (USA)
The Digital Video Colposcope system is a powerful high definition camera and imaging module used for clinical examinations of the cervix, vulva and vagina. The SONY high definition CCD imaging module and super bright LED light source, provide high quality images for clinicians to see pathology changes. This video colposope is different from traditional optical colposcopes because instead of ...
Manufactured by:AMD Global Telemedicine, Inc. based inChelmsford, MASSACHUSETTS (USA)
The Digital Wireless ECG is a PC based 12-Lead EKG system that wirelessly streams ECG data from the patient to your personal computer. The process is simple: perform the patient hookup, input patient data into the software, and then start the analysis. Our system uses the Glasgow 12-Lead algorithm to output fully interpretive ECG statements. Reports include Global Measurements, Individual Lead ...
Manufactured by:Shoulder Innovations based inGrand Rapids, MICHIGAN (USA)
Genesis is an early stage investor in medical device technology. We are differentiated through our deep level of engagement in delivering value through all stages of the commercialization process. This is accomplished by leveraging the time, talent, and financial resources of the Genesis Innovation Group Portfolio. ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Small Medical Device Companies Can Now Manage and Automate their Design Control Process to Ensure Compliance with 21 CFR Part 820 with the Help of MasterControl's Design Control Software Systems at a Low Monthly Cost. Each manufactured medical device must be supported by appropriate documentation which demonstrates that its ...
Manufactured by:Nextern Inc based inWhite Bear Lake, MINNESOTA (USA)
We are your sole partner to provide seamless connected medical device development solutions. Leveraging our experience and expertise in medical device design, cloud architecture, and mobile engagement ...
Manufactured by:Coala Life Inc. based inIrvine, CALIFORNIA (USA)
Coala is a medical device that allows for long-term, non-invasive and algorithm driven cardiac monitoring. No patches, no burden, no limitations in time. Coala offers real- time, algorithm based detection of cardiac events including event notification. ...
by:Vintara based inOakland, CALIFORNIA (USA)
Vintara’s Enterprise Portal helps leaders deploy world class best practices for the manufacture and sale of medical devices. Our configurable workflow applications will drive performance and world class regulatory compliance including: ISO 13485, 21 CFR Part 11 compliance, 21 CFR Part 820 compliance, CAPA, Device Master Records, Customer ...
by:Centaur Labs based inBoston, MASSACHUSETTS (USA)
Audio clips from medical devices are critical indicators of patient health, and can be leveraged to train predictive algorithms that detect heart conditions, lung abnormalities, and more. Our annotation platform is tailored specifically to medical audio clips, with features such as range selection, spectrogram integration, and motion data ...
Manufactured by:Syncro Medical based inLanghorne, PENNSYLVANIA (USA)
Cutting edge medical instrument manufacturers are uncovering the hidden value of the data collected and generated by their systems. With Syncro Medical’s help, they’re using this data to gain new insights, both Clinical and Operational. Clinical healthcare analytics focus primarily on the patient, for example patient outcomes or ...