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Hello,

Does anyone know the pros and cons / gap analysis of being audited for ISO 13485:2016? Currently we use ISO 13485:2003/EN ISO 13485:2012.

Thanks.

Hello Zain -

I would recommend attending an ISO 13485:2016 transition training session to fully understand the extent of the changes. The changes are numerous and will require updates to your quality system to achieve compliance. Annex A at the back of the 2016 standard outlines the changes in the 2016 version as compared to the 2003 version. ISO 13485:2016 is intended to supersede ISO 13485:2003 I believe on 4/1/2019 so you would need to recertify to the 2016 version by then.

Hope this helps.

Jennifer

Hello,

Does anyone know the pros and cons / gap analysis of being audited for ISO 13485:2016? Currently we use ISO 13485:2003/EN ISO 13485:2012.

Thanks.