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Drug Device Software
10 software items found
by:DNAnexus, Inc. based inMountain View, CALIFORNIA (USA)
DNAnexus GxP Support ensures that your drug or device development work complies with best practice standards, at every ...
by:Verana Health based inSan Francisco, CAMBODIA
Qdata spans three therapeutic areas-ophthalmology, neurology, and urology—and reflects deep patient journeys across robust demographics. Qdata helps to unlock quality research insights along the entire drug and medical device development lifecycle, from clinical trial site and subject identification through to post-market evidence generation and opportunity ...
by:Bayoonet AG based inDarmstadt, GERMANY
Digital health applications are CE-marked medical devices that can be prescribed to patients with statutory health insurance. They are used in the diagnosis and treatment of ...
by:DDi LLC based inPrinceton, NEW JERSEY (USA)
VISTAAR provides Global Regulatory, Clinical and Compliance Requirements to Biopharma, Devices, Consumer Health, Cosmetics, and Digital Health. With a unique combination of smart technology and subject experts, you will get up to date requirements and trusted insights accurately and much faster. Over many years, VISTAAR has built deep data sets to help you do the right strategy. All this is done ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Customer complaints management software helps regulated companies reduce complaint resolution time. Mistakes are inevitable. That’s not an excuse; it’s a fact of doing business. Unfortunately, in the life sciences and general manufacturing industries, mistakes can result in more than disgruntled customers and a barrage of complaints; they can result in serious safety issues, even ...
by:S-Matrix Corporation based inEureka, CALIFORNIA (USA)
Fusion Process Development (FPD) is a general Design of Experiments (DOE) module which plugs into the Fusion QbD platform in the same fashion as the Fusion LC Method Development (FMD) and Fusion LC Method Validation (FMV) modules. It connects into the same Fusion Administrator controlled 21 CFR 11 Regulatory Compliance and Workflow Management System feature sets, and has the same internal ...
by:S-Matrix Corporation based inEureka, CALIFORNIA (USA)
Fusion Inhaler Testing (FIT) creates Device Sampling Designs for metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). It supports USP Apparatuses 1–6, Ph.Eur. Apparatuses C, D, and E, and Dose Unit Sampling Apparatuses (DUSAs). FIT also creates coordinated HPLC Testing Designs that are directly exportable to your Chromatography Data Software (CDS) — connectivity includes ...
by:Empatica Inc. based inBoston, MASSACHUSETTS (USA)
Empatica Care enables the continuous, remote monitoring of patients with acute and chronic conditions, or of healthy individuals who may be at risk of infection, by easing the burden on healthcare workers and facilities, and simultaneously increasing the quality of care that can be provided to ...
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:BrightInsight, Inc based inSan Jose, CALIFORNIA (USA)
The leading global regulated Digital Health platform for biopharma and ...