Idonea-Solutions, Inc.

medical devices

About

Provides consulting services to small to mid-size Medical Device manufacturers. The company has successfully completed several projects for medical device manufacturers. Medical Devices worked on include, - X-ray, - Neurosurgery Instruments and Fixation Devices, - Radiotherapy Accessories, - Pupillometer, - Electromyography based seizure detection device - Neurostimulation devices - Transcatheter Aortic Valve and delivery system - Ultrasound based acute pain and Foley catheter accessory devices - COVID-19 Home Test Kit - 3D Dental Scanning device We serve a significant number of small and mid-size medical device OEMs. Our knowledge, experience and the ability to be involved in all aspects of medical device allow us to undertake all types of projects. We have established great working relationships with 3rd party test facilities that specialize in the areas of; - Usability Study - Testing for compliance with a wide variety of international standards - Biocompatibility and Pre-clinical Animal studies

Technologies

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Keywords

product development design design & execution of preclinical testing eua de novo clinical trials device distribution regulatory authorizations pma development ce mark facility registration & device listing verification & validation testing quality assurance establish andor maintain quality system for medical device oem ide etc preide 510 regulatory submissions device & est registrations medical equipment manufacturing health care health wellness & fitness hospital & health care medical devices

Location

Chadds Ford, Pennsylvania, United States, 19317

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