International Regulatory Compliance

 

Regulatory Page - Reg Officials & Dr

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 million 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 PharmaSmart 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 ‘A.’ It is well suited for its role as a high volume, self-administered BP screening device.

 

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
 www.EmergoGroup.com 

 

Notified Body/ Registrar / Certification Body

Pharma-Smart International, Inc. maintains ISO 13485:2003 certification and is audited every year by: SGS United Kingdom Ltd

Systems & Services Certification
 Rossmore Business Park
 Ellesmere Port
Cheshire CH65 3EN UK.  




Downloadable PDF


QUALITY MANAGEMENT SYSTEM ISO


ISO 13485 quality system certification

 ISO 13485-2003 EN ISO-2012 Cert Feb 25 2015 thru Jan 23 2018

 Directive 93-42-EEC Cert Feb 25, 2015 thru Jan 23 2020

 ISO 13485-2003 Cert Feb 25 2015 thru Jan 23 2018

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

Canadian Medical Device License

 CSA

 

Europe – CE Marking Certificates 

 Directive 93-42-EEC Cert Feb 25, 2015 thru Jan 23 2020

 

UNITED STATES – FDA 510(k)

 PS – 1000 | PS – 2000

 

 

 



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