ISO 27001 is one of the standards that help organisations keep information assets secure. Those information can vary from financial information, intellectual property, employee details, customer personal data and any other information entrusted to you by a third party.
Today’s medicine is evolving quicker than it ever was. With the emergence of new diseases and all the new ways they can spread across the world, it is necessary that there are worldwide requirements put on all medical devices if we want to have any chance of winning.
ISO 13485 is a harmonized standard that specifies requirements for quality management (QM) or the QM systems of medical device manufacturers.