Must be applied by 22 May 2018!
This is the probably the last update to this standard as it will be replaced by EN 55035
One of the main changes is the option of using a 4 % step size for continuous conducted immunity test now deleted!
Must be applied by 22 May 2018!
This is the probably the last update to this standard as it will be replaced by EN 55035
One of the main changes is the option of using a 4 % step size for continuous conducted immunity test now deleted!
Just a reminder! – the European Commission published a “new” version of “The ‘Blue Guide‘ on the implementation of EU product rules 2014″, (the so called “Blue Book“), in July this year
The new ‘Blue Guide’ builds on the on the content of the Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) published back in 2000, but reflects the modernisation brought to the legal framework in the past decade.
This is not an update as such, as there has been no change to the content – the only difference is in the formatting
ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:
ISO 13485:2015 is due to be published early 2016.
The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.
Some of the key changes include:
* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:
* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you
* Learn more about the ISO 13485 revision
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“New” version of the CE Marking “Blue Book”
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