Understanding & implementing the key changes in ISO 13485:2016
With the revised version of ISO 13485 published in March 2016 and considering that we are now well into the transition process, all medical device manufacturers are advised to start their transition immediately if they haven't already done so.
As all new certifications and re-certifications must be to ISO 13485:2016 after 1 March 2018, LRQA is delivering a webinar to help medical device manufacturers understand & implement the main changes introduced.
During the webinar, experts from LRQA will explain the main elements of the ISO 13485 revision and guide manufacturers on how to determine their readiness for assessments against the revised standard, in order to ensure that their plans are aligned to achieving certification within the defined timescales.
Date: Wednesday, 24 May 2017
Duration: 45min followed by 15min Q&A
Speakers: John Howlett & Flemming Nielsen
- Background to the revision and its relationship with ISO 9001
- Key changes within the ISO 13485:2016 revision
- Main points and emphasis of the revised standard
- Determining the readiness of your organisation
- Implementation – Timescale & challenges