Recently, there has been a significant transition in “medical-grade” nomenclature that has begun to permeate the parlance of orthodox natropathic circles-particularly as it relates to medicinal applications. While much of the subject matter narrates the qualification and subsequent evolution of various herb specie as a medicine, very little has been made applicable to the legitimization of ancillary products. As a result, Phoenician Engineering considers our products to be true medical devices designed to define the medical-grade ancillary product standard. Accordingly, we have voluntarily structured our Quality Management System in alignment with the regulatory and compliance standards of ISO 13485:2003 and are currently seeking conformance.
Phoenician Engineering operates under the premise that legitimate medicine should be complemented by legitimate medical devices. Ultimately, the distinction amongst ancillary products designated as medical-grade or otherwise occurs in process qualification-not marketing efforts. Our product realization process from sourcing domestic DFARS certified material to the implementation of FDA approved medical device packaging is substantiated by our patient-centric focus. Every input in the manufacturing of our product is supported by a process that yields superior quality and value to the user. Collectively, these processes differentiate our products not only with regard with our efforts in ISO conformance but also with our commitment to setting the medical-grade benchmark.
As implied, cleaning involves the removal of visible and non-visible soil and other debris. We accomplish this process through the use of an ultrasonic cleaner with an aqueous medium ranging from moderately alkaline or neutral synthetic to high caustic contingent on material and soil considerations. Ultrasonic cleaning offers unparalled benefits in removing soil and debris accumulated during the manufacturing process due to the high frequency sound waves ability to clean without damaging the device. During the decontamination process, liquid chemicals are used to kill non-spore forming bacteria and depending on the application, we will employ Isopropyl Alcohol (70%), Sodium Hypochlorite, or Ethyl Alcohol.
In the end, Phoenician Engineering products speak for themselves. We don’t compromise and we don’t endorse anything short of excellence. This commitment enables us to provide the best ancillary products to the patients, physicians and cultivators we serve. Fundamentally, medical-grade is much more than a buzzword or sales rhetoric. It is a commitment, an evolution, and a mission in itself. We are Phoenician Engineering. Welcome to medical-grade.