In a nutshell, what does the industry need to do? John Lafferty has broken down the requirements in the following three elements ġ. Records of such activities shall be maintained”. The specific approach and activities associated with the software validation and revalidation shall be proportionate to the risk associated with the use of the software. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.

ISO 13485:2016 Section 4.1.6 “ Quality management system, General requirements” and 7.5.6 “ Validation of processes for production and service provision” state the following “ The organisation shall document procedures for the validation of the application of computer software used in the quality management system. Software Validation Assistance/Consultancyġ) How to meet the Software Validation Requirements of ISO 13485:2016 – 3 key elements.Software Validation of Outsourced Processes.Validation of Software Used in Manufacturing Processes and Test Equipment.Examples of computer software used in the Quality Management System.How to Categorise the Software Used at your Medical Device company.A suggested layout of documenting risk within the Master Validation Plan.How to meet the Software Validation Requirements of ISO 13485:2016.In this blog, our expert Tutor, John Lafferty aims to help you deal with the process of validating software used in the manufacturing/testing of medical devices and software used in the Medical Device Quality Management Systems. With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, it is a challenge for the industry to obtain suitably qualified software validation engineers to fulfil its requirements. Understanding the Software Validation Requirements of ISO 13485:2016

En iso 134852012 for software