What is a certified ISO 13485 manufacturing facility?
ISO 13485 Medical Devices - Quality Management Systems - Requirements for regulatory purposes is an international standard designed to provide medical device suppliers with a common approach to applying a Quality Management System that addresses most FDA requirements. It is based on the popular ISO 9001 series with the ISO 13485:1996 standard based on the ISO 9001:1994 standard and the new ISO 13485:2003 standard based on the ISO 9001:2000 standard (and includes the old ISO 13488).
The intent of ISO 13485:2003 is to provide for the development of a Quality Management System that ensures to prospective customers and regulatory bodies that the goods and services offered by the organization will meet customer and regulatory requirements.
What type of "after sale" support do you offer regarding the servicing of equipment and follow up training visits?
Genesis Biosystems has an excellent team of customer service and technical support personnel. If you have a problem with your microdermabrasion machine, please call our Technical Support at 01245 227752. You will be able to speak with one of our Technicians who can troubleshoot most of your technical issues without having to return your system to us for service. Genesis Biosystems also offers a Perpetual Warranty Program on every Derma Genesis® microdermabrasion machine. (See our Perpetual Warranty Program for details.) By taking advantage of this unique program, you will not be charged for any repairs throughout the remaining life of your machine. We can also provide a loaner device within 24 hours if needed. Our goal is to ensure you never have downtime in your office.