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
ALL TESTS & PROTOCOLS MEET OR EXCEED ALL REGULATORY STANDARD
REQUIREMENTS INCLUDING:
ISO, FDA GUIDANCE DOCUMENTS, MDD, ASTM, AAMI, ANSI, IEC, BHA
