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Medical Device Software Available In In Usa
104 software items found
by:Emperra GmbH E-Health Technologies based inPotsdam, GERMANY
The ESYSTA Portal seamlessly displays the blood glucose values, carbohydrate units and insulin doses sent to it. Special algorithms analyse each patient’s data and evaluate it continuously. A quick summary of critical values or incorrect doses, coupled with rapid communication between the doctor and the patient, brings a new dimension of quality to the treatment of ...
by:Epihunter NV based inHasselt, BELGIUM
Epihunter Pro makes the automatically built seizure diary available through a webportal for the physician. The epihunter home-care solution is based on a wearable EEG headband and a smartphone with a detection algorithm. When a seizure is detected, the people around are notified immediately. Next to this, an entry is automatically logged in the seizure diary. Also, a video can be automatically ...
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:MDI Solutions based inToronto, ONTARIO (CANADA)
100% software solution that integrates vital signs information from medical devices with the patient record. Enovacom Patient Connect is a unique connectivity solution that extracts vital signs and other patient information from biomedical devices and integrates this directly with the patient record. This 100% software-based solution delivers ...
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:Orcanos Israel based inGivatayim, ISRAEL
Our medical requirements management tool is perfect for manufacturers of medical devices and will provide you with a number of essential quality-related ...
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:Covartim based inWatermael-Boitsfort, BELGIUM
A standalone software, such as a mobile or web application, can fall within the definition of a (IVD) medical device. Therefore, the placing on the market is well regulated and specific actions need to be ...
by:qmsWrapper based inToronto, ONTARIO (CANADA)
The combination of Jira with qmsWrapper introduces a system in which MedDev companies are able to track, manage, and organize all CE Technical Files and FDA Design History Files, while enabling software development of medical ...
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. ...