5 Focus Areas of the ISO 13485 Medical Devices Quality Standard
Are you looking forward to getting the ISO 13485 standard for your medical device business? Well, to obtain compliance with the standard, you need to learn about its key requirements which are an impressive addition to the general standard, ISO 9001. The requirements of the ISO 13485 standard emphasize the quality and safety of the devices that are manufactured, assembled, distributed, sold, and serviced by a company. Having the standard certification implies that your medical device company has a dedicated management system in place that helps to assure the quality, safety, and consistency of your medical devices. So, to prepare your medical device business for the certification, you need to learn the key areas it focuses on. We will go over those below. 5 Key Areas of Focus for the ISO 13485 Standard for Medical Device Quality Management QMS Requirements The standard first emphasizes the requirements for establishing, operating, and maintaining the Quality Management ...