International Regulatory Compliance
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 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.
Notified Body/ Registrar / Certification Body
PharmaSmart International, Inc. maintains ISO 13485:2016 and MDSAP certification and is audited every year by Intertek.