Hi Nevada, I am an Australian technical writer who has worked on ISO projects in the past particularly for quality management systems. Do you have a copy of ISO 13485:2016? I can also take a look at your technical files and possibly upgrade them as well. It depends on what they are and what you need.\r\n\r\nWith more than 20 years experience as a technical writer, I have worked with companies such as Raytheon Australia and BAE Systems. Although not medical, I have worked on medical projects in the past. Since then I have worked on countless freelance projects with success. Please see my portfolio and reviews.\r\n\r\nI invite you to open a conversation abut your project requirements.\r\n\r\nThank you