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Quality

Etrending_Label

Etrending® was developed by PHD Medical using strict medical device quality management systems to control both its development and deployment. The Quality Management System (QMS) drives the effectiveness and continuous improvement of all our business systems, processes, procedures, work instructions, forms and records to meet the stringent requirements of international medical device regulations. All product and services produced by PHD Medical are realized using a robust risk management process in accordance with ISO 14971. Our goal is to exceed customer expectations by providing dedicated, value-added support service. PHD Medical has been awarded certification to ISO-13485, ISO-9001, and European Medical Device Directive 93/42/EEC with zero nonconformance's on the first attempt.

PHD Medical has been granted approval by the Food and Drugs Administration & the Health Canada Therapeutic Products Directorate for a number of products. The complete development life cycle for the Etrending® complies with the QMS in place for sister products.

The etrending management team is committed to ensuring that customer, regulatory, quality and operational performance requirements are understood, planned, implemented and effective, at all levels of the organization.

PHD Medical Inc. has been accredited with the following quality standards:
ISO 9001:2008
ISO 13485:2003
Canadian Medical Device Regulations as per Standards Council of Canada
FDA Part 820 of title 21 CFR
Medical Devices Directive 93/42/EEC Annex II