LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development.
Document management software tailored to your business Providing improved visibility and control for the development process for Semiconductors and medical device businesses. Medical Devices A flexible eQMS platform designed for your medical device development or IVDR compliance. Validated for ISO 13485 with...
The medical document management device includes: a medical document database 18 for storing medical documents of a plurality of hospitals; terminal equipment 14; and a management device 16 for receiving electronic medical documents transmitted from the terminal equipment 14, and for acquiring dates and...
New IMDRF document on Medical Device Software ByMitchon Friday, 29 March 2024, 13:42 -Regulations Guidance risk management SaMD The IMDFR organization published in January 2024 a new document onMedical Device Software: Considerations for Device and Risk Characterization ...
Grow your Medical Practice with PrognoCIS EHR/EMR, cloud based Medical Office Software, Practice Management, Billing & Patient Portal.
Risk Management Process and Methods: ISO 14971, IEC 60812 Medical Software Development: IEC 62304, AAMI TIR 45 and SW 96 Human Factors and Usability Engineering: HE 75, IEC 62366 Areas within the medical device/life sciences space Jama Software supports includeMedical Devices, Diagnostics (IVDs, ...
Device Company "We approached Promenade about creating an end-to-end solution software platform fully compliant with FDA requirements, quality systems management and FDA grade deliverables. Promenade gave us a spectacular product." Dr. Erik Won, ...
MasterControl's integrated Medical Device Quality Control software provides complete quality assurance management to meet regulatory requirements.
Improved transparency and traceability of medical device design control data Granular traceability of design evolution is a catalyst for reduced time to market, better risk management and superior design quality. Empowering mechanical, electrical, and software teams to author and manage design con...
Designanddevelopmentofamedicaldevicemaintenancemanagementsoftwaretokeepandassign recordofmedicaldevices,theirinformation,maintenanceprotocolsandrepair/maintenancehistories;theforegoingmaintenancedates,andthetechnicianresponsibleforthem; toinformthetechnicianaboutthemaintenance;tocarryoutandcomplete...