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Update on Three Medical Device-Related ISO Standards

Update on Three Medical Device-Related ISO Standards

Written by John Lafferty



Read time: 1 minute

ISO/TR 20416 on post-market surveillance (Guidance) 

•Inspired by EU MDR/IVDR 
•Draft Technical Report (DTR) ballot was successful and comments were resolved in Oct. 2019 
•Publication expected in early 2020 
•An (EN) European version will be developed. 

ISO 20417 on information to be supplied by manufacturers 

•Inspired by EU MDR/IVDR 
•Intended to replace EN 1041:2008 + A1:2013  
•Draft International Standard (DIS) ballot was successful, now in process for Final Draft International Standard FDIS ballot. 
•Publication expected mid-2020

ISO 15223-1 symbols for use with medical devices – general requirements 

•Inspired by EU MDR/IVDR 
•20 new symbols currently proposed 
•Publication of ISO/DIS 15223-1 expected December 2019 

You can follow the Northridge Quality and Validation LinkedIn Company page for more updates.

About the Author - John Lafferty 

John Lafferty is the owner of the Northridge Quality & Validation which provides consultancy to the Medical Device industry. 

Specialities 
His specialities include Software Validation, MDSAP, ISO 13485, ISO 14971 and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education, Certificate in Quality Management.

Experience
He has over 25 years’ experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe.

SQT Training Tutor
John is also a Life Sciences Tutor with SQT Training

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