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  CLINIMARK         Clinical Testing & Validation Services for Medical Devices

80 Health Park Dr. Louisville, CO 80027
(+US) 303-926-5432

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 Clinimark
CLINICAL TRIALS FOR MEDICAL DEVICES

CLINIMARK IS A HUMAN PERFORMANCE LABORATORY THAT TESTS PHYSIOLOGICAL MONITORING DEVICES; AIRWAY DEVICES; VENTILATORS; NEW INOVATIONS

WE PROVIDE CLINICAL TESTING IN HOSPITALIZED PATIENTS AND LABORATORY TEST VOLUNTEERS DURING DEVELOPMENT AND FINAL ACCURACY VALIDATION FOR SUBMISSION TO THE FDA AND OTHER REGULATORY AGENCIES.

CLINIMARK HUMAN CLINICAL TESTS INCLUDE:
PULSE OXIMETRY
BLOOD PRESSURE RESPIRATORY RATE TEMPERATURE MONITORING
 – CARBON DIOXIDE MONITORING ECG RESPIRATORY GASES AIRWAY DEVICES
– AND CUSTOM CLINICAL TRIALS FOR MANY ADDITIONAL TYPES OF DEVICES

 Publication Services Usability Analysis In Vitro Blood Lab 

 DATA FOR FDA SUBMISSIONS MEET FDA GUIDANCE DOCUMENTS
ALL TESTS & PROTOCOLS MEET OR EXCEED ALL REGULATORY STANDARD REQUIREMENTS INCLUDING:

ISO, FDA GUIDANCE DOCUMENTS, MDD, ASTM, AAMI, ANSI, IEC, BHA

 A hallmark of Clinimark service is confidentiality.  All studies at Clinimark are confidential – we do not make identity of the sponsor-manufacturer public.

 Pulse OximetryBlood PressureRespiratory RateTemperature Additional ParametersAirway Device Testing Services