Even though receiving an ISO certification is not a necessity, a lot of companies these days are venturing towards receiving a certificate because it improves the value and effectiveness of their company and its operations. ISO 13485 is a recognized standard within the medical industry which provides a framework to follow to ensure that businesses dealing with medical devices are complying with all requirements and that they are performed accurately. ISO 13485 specifies the requirements for qualified companies looking to demonstrate their abilities to provide medical devices that will constantly meet their customers needs and regulatory requirements. These requirements can be applied to medical equipment, procedures and related services. The main purpose for the ISO certification is to simplify the synchronization of quality management systems with the medical device regulatory requisites while providing safe and effective medical devices. The requirements of ISO 13485 are for any organizations that provide medical devices, despite the organizations type or size. It is the organizations responsibility to conform to all ISO 13485 regulations.
The processes required by ISO 13485, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system (www.ISO.org).
BC Technical is proud to be ISO 13485 certified. We are adamant about following the processes necessary in order to ensure complete compliance with every requirement. BC Technical is the largest non-OEM provider of Medical Imaging Solutions. Our ISO 13485 certification and FDA registration ensure exact medical device standards are met with all of our refurbished systems, parts and service. All of our parts conform to ISO-13485 standards. What is unique about BC Technical is that we renew our certification on a yearly basis. We endure the thorough audit because we want to demonstrate to our customers the dedication of our company and to show our desire to follow the most stringest parts-quality-assurance processes in the industry! Not only are all our parts system tested, they also are backed by a 150 day warranty.