The standard covers all aspects of the device’s design, fabrication and performance, from the research and development phase to the production and distribution. It also requires that the company has a documented quality management system in place to ensure that the product is safe and effective for its intended use. This includes the training of personnel, preventative maintenance, calibration of equipment and the documentation of all activities related to the production of medical devices.
ISO 13485 is also important for our company as it helps to ensure that our products meet all applicable regulatory requirements. This is important to ensure that our products are safe and effective for their intended use. Adherence to the standard also helps to demonstrate to our customers that we are committed to providing the highest quality products and services.