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The Machine Age
By: Annet King
Posted: June 24, 2008, from the February 2006 issue of Skin Inc. magazine.
page 4 of 7
Read the fine print. If decoding warranties isn’t your strong point, show it to someone who comprehends legalese. Make sure that you understand the terms, and establish that the manufacturer is prepared to cover repairs in a responsive, responsible manner. What will the company do if your machine breaks down and you have eight appointments booked for the next day? If no one from the maker’s sales office can explain and verify the warranty, and cannot or will not answer your questions, move on. You do not need that piece of equipment, no matter how exciting it may appear at the tradeshow.
Before you purchase any type of equipment, confirm that the manufacturer meets the following criteria.
• It is registered with the U.S. Food and Drug Administration (FDA). If a company states that because they do not make medical claims, they are exempt from FDA regulations, they are mistaken. Beware, and don’t deal with it.
• It carries product liability insurance. This coverage protects you in the event of a product or device failure or malfunction that may cause damage or harm.
• It is ISO 13485:1996 certified, meaning certified by the International Organization for Standardization. This is an official recognition that further safeguards you. Most manufacturers of Class 1 devices are not inspected consistently by the FDA; however, ISO inspects twice a year.