Approvals, Licenses & Certificates
All Companies that claim their machines are made in the USA must comply with FDA Quality System Regulation Title 22 Part 820 quality management system & procedures, ISO 13485, safety and performance.
NeurotriS / A-1 Engineering has taken the necessary steps to be above all others and maintains a current license to manufacture and sell worldwide.
“I have reviewed the remaining quality procedures that were noted on the Notice and they were found sufficient. Your firm is found to be in compliance and I will go ahead and close out the inspection”.
CDPH – Food and Drug Branch
Medical Device Safety Unit