Blood Pressure
CLINIMARK provides Clinical Trials (Accuracy Validation) in
Non-Invasive Blood Pressure (NIBP) and Invasive
Blood Pressure (IBP) for Regulatory
Submissions [FDA 510K, MDD, etc]
In addition to standard accuracy testing, CLINIMARK designs studies
that target specific requirements or patient populations for blood
pressure measurement. We offer clinical trials in all areas of the
hospital including the Cardiac Catheterization Laboratory, Critical
Care Units, Operating Room and more.
CLINIMARK Blood Pressure Testing also
includes:
Customized Human Factors Testing for Design & Development prototypes
Fit & Function testing including Ease of Use and Ergonomic studies
Usability validation with clinicians of all disciplines &
specialties
CLINIMARK Blood Pressure studies &
PROTOCOLS are registered with
ClinicalTrials.gov and MEET OR EXCEED ALL REGULATORY STANDARD
REQUIREMENTS INCLUDING:
ANSI/AAMI SP10, ISO 81060 (2009), FDA GUIDANCE DOCUMENTS, MDD, ASTM,
IEC, BHA
