Save up to £100 off selected courses! Enjoy savings on ISO training this Winter. Study in a traditional classroom at one of our UK training venues, or learn from the comfort of your home via a virtual classroom. Our virtual courses are taught by [...]
At Batalas we appreciate that the world of ISO, management systems and auditing can be quite baffling at times, but fear not as our expert trainers are here to help! This week we look at "What is ISO 13485?" [...]
What is the difference between ISO 13485:2016 and ISO 9001 Overview ISO 9001:2015 was released in September 2015, and many expected the new ISO 13485 to be based upon this new ISO 9001 standard. But the work on ISO 13485 had gone on for [...]
ISO 13485:2016 - Medical Devices Quality Management Systems - Requirements for Regulatory Purposes The international Medical Devices Quality Management Systems (QMS) ISO 13485 standard was revised and published in March 2016, giving us ISO 13485:2016. Why update the standard? [...]
Voting has now closed on the next revision to ISO 13485 "Medical devices — Quality management systems — Requirements for regulatory purposes". All comments received by the ISO/TC 210 working group (the ISO group that is revising the standard), the comments will now be reviewed [...]
There are big changes coming up in the regulation of European medical devices, with anyone who sells medical devices in the European markets likely to be affected. Ineffective processes and regulations are likely to be weeded out, with changes likely to be applied across the [...]
Sales volumes of blood pressure monitors look set to rise across the world in coming years as the population ages, isuppli.com reports. As populations across the world become healthier – and therefore start living longer – the need to monitor blood pressure is only set to rise. [...]
The ISO 13485 Medical Devices Standard has recently been updated, but only for the UK and the Rest of Europe. […]
An explanation of the key differences between ISO 9001: 2008 and ISO 13485 : 2003. This document has been updated. If you are looking for the latest ISO 13485:2016 comparison please click here ISO 13485 : 2003 is based upon ISO 9001: 2000, but [...]