Device / rules and regulations
STATE AND FEDERAL RULES AND REGULATIONS
regarding device usage and manufacturing have always been very ambiguous, to say the least…
What questions should you ask your manufacturer or equipment supplier?
… Is the manufacturer ISO 9001 and ISO 13485?
This is essential to verify. Each manufacturer should have both ISO certificates available, and they should be willing to email these to you upon request.
Verifying this information ensures that the manufacturer of supplier is compliant and adheres t the required safety and quality systems set forth by the government’s good manufacturing quality standards ISO 13485 is crucial to verify, as to represents the highest accepted device-manufacturing standards recognized worldwide. If a company maintains these registrations, you can rest assured that they are audited annually. This means that they are likely a compliant manufacturer or supplier who adheres to the highest quality and safety practices recognized worldwide, regardless of where they are located…
Team Rejuvee