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Thank you all for the responses!!  During our last audit 9001 & 13485 at our MX facility our BSI auditor mentioned keeping our 9001 for COFEPRIS requirements, but I cannot find anything in the regulations.  I'm wondering if she was talking about what Richard mentioned above regarding tenders/contracts ...

Hello all! Does anyone know if ISO 9001:2015 certification is required for medical device sale in any region of the world (specifically Central or South America countries)?  Is there any reason a company would need to be certified to both 13485 and 9001? Thanks! ------------------------------ Melinda ...

Hello!  We utilize RCRI (now Covence). They are very knowledgeable on EU MDR and rev 4 of the MEDDEV. ------------------------------ Melinda Smith MS, RAC VP, Quality and Regulatory Affairs Roswell GA United States ------------------------------

I'd like to get some opinions of how to address the FDA versus ISO definition of correction.  FDA defines correction as "the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other ...

No, this does not require NB notification. This is a marketing change to the label that does not impact the device’s compliance with the ERs. Thanks, Melinda Please excuse any typos or brevity. Sent from my iPhone.