Upgrade QMS 13485:2013 to ISO 13485:2016

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

Hello, I'm a medical writer. I focused on providing great content on medical related topics. I have done this for years. My experience and skills in writing will help work on that aspect of clinical evaluation update mentioned in the job description.

Hello , i am a qualified pharmacist working in France . Error being hardly acceptable in the patient management , the organisation of health care centers must be constantly improved . We health practitionner in france are trained to ensure good quality practices ( i have a certification ) , and it would be of a great pleasure to help you in that process . For example I participated in the making of a process to make sure the patient's prescription is not modified upon ER entrance .

Hi How are you? I can help with parts of your project.... I have many years experience in the medical device industry, in roles such as; quality systems, risk management. I am a certified lead auditor for ISO13485:2016 and have a certificate in medical device risk management (certificates can be provided on request). I am also knowledgeable on the requirements of MDR2017/745 and clinical evaluation and technical file requirements of this regulation (I'm not familiar with regulatory requirements of countries adopting MDSAP; just Europe). Please don't hesitate to contact me if you would like to chat about this project as I would be very interested. Thanks Stephanie