Electromedical Technologies Achieves ISO 13485 Certification

Electromedical Technologies Inc., a pioneer in the development and production of bioelectronic devices, has passed the ISO 13485:2016 recertification audit for Medical Device and Quality Management Systems. This designation demonstrates that the company’s facility meets all of the requirements to design and manufacture medical devices.
 
An internationally recognized standard of quality and safety for medical device industry, ISO 13485:2016 certification affirms the company’s commitment to the highest quality standards from the design phase through production. The firm is currently in Phase 2 of prototype construction of the new WellnessPro POD. Once complete, the device will be used in a 510(k) medical device submission to the U.S. Food and Drug Administration (FDA). WellnessPro POD is positioned as a new, smaller, professional grade wearable device for mass market retail customers seeking non-opioid therapy to treat chronic pain and has the ability to work with the flagship Wellness Pro+ device currently in the market. 
 
Matthew Wolfson, founder and CEO of Electromedical Technologies, noted, “We are pleased to announce our successful passing of the ISO 13485 recertification. This designation is a testament to our quality control procedures along with our innovation. We strive to design and manufacture the most effective, non-invasive bioelectronic devices for pain sufferers seeking alternate therapy choices to drugs. Patients suffering from chronic and acute pain have had greater difficulty dealing with their conditions during the current COVID-19 pandemic. This is making the Opioid health crises even worse. We believe our offerings are primed to serve as the go-to alternative that uses physics instead of drugs to relieve pain.”
 
Headquartered in Scottsdale, Ariz., Electromedical Technologies is a commercial stage, FDA-cleared, bioelectronic medical device manufacturing company initially focused on the treatment of various chronic, acute, intractable, and post-operative pain conditions. Through university collaboration agreements, the company is working to develop a comprehensive research program in defining the effects of electro-modulation on the human body. By studying the impacts of electrical fields in cell signaling and effects on virus assembly and immune responses, the company’s goal is to reduce pain and improve overall human wellbeing. The company’s current FDA-cleared product indications are for chronic acute post traumatic and post-operative, intractable pain relief.