PharmaSmart International Inc., designs, manufactures, and distributes innovative blood pressure screening systems to assist in the detection and management of hypertension. For over 20 years PharmaSmart has served its customers while continuously advancing research and development of its clinically validated Class II – Non-Invasive products.
PharmaSmart’s existing network of blood pressure machines successfully administers more than 65,000,000 Blood Pressure tests annually.
PharmaSmart blood pressure screening system technology and patented cuff design has been clinically evaluated for compliance with The Association for the Advancement of Medical Instrumentation’s standard (AAMI) and to a modified British Hypertension Society (BHS) Protocol. The clinical study was performed at the University of Tennessee, and the results were published in the technical research journal Blood Pressure Monitoring (vol 9, no 1).
The study concluded: "The Pharma-Smart PS-2000 met the AAMI requirements for accuracy. Most notably, the mean difference between well-trained clinicians and the device readings were very small (0.07 systolic and –0.3 diastolic). Further, when analyzed in accordance to the BHS evaluation protocol, the PS-2000 achieved the highest grade - an 'AA'. It is well suited for its role as a high volume, self-administered BP screening device."
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification
ISO 13485:2003 certificate
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
PRODUCT CERTIFICATIONS AND APPROVALS
CANADA- Medical device licenses
PS-1000 | PS-1500 | PS-2000
EUROPE - CE Marking certificates
PS-1000 | PS-1500 | PS-2000
UNITED STATES - FDA 510(k) cleared/PMA approved devices
PS-1000 | PS-1500 | PS-2000
Certificate To Foreign Government
PS-1000 | PS-1500 | PS-2000
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Pharma-Smart LLC maintains ISO 13485:2003 certification and is audited every year by:
SGS U.S. Testing Company Inc.
Houston, Texas USA
Telephone: +1.281.873.5800
www.us.sgs.com