Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
We’ve been talking about getting ready to meet the ISO 13485:2016 deadline for a while now, urging organizations to perform regulatory gap assessments, get a compliance update plan in place, and execute. In fact, I just reminded everyone again a few days ago in my blog about the steps to take to get compliant prior to March 1, 2019. So do we really need to address it again? Well, yes, because it is that urgent!
If your organization is currently certified to the ISO 13485:2003 standard, then it is important for you to know that before March 1, 2019, re-certification to ISO 13485:2016 will be required for your organization. You’re probably thinking that’s over a year away, we’ve got time! But consider this — from personal knowledge I can tell you that you are definitely not alone in the need to get this done within the next 12 months, and the queue for ISO 13485:2016 certification is long! Therefore, if you’re not done yet, or you haven’t even started, get some help to expedite the process.