Medtech Snapshot: Trisha Aure - Differences Between ISO 13485 and 21 CFR 820 (Highlights)

In this 2-part series of Medtech Snapshot we're joined by Square-1 Engineering Director of Delivery & Operations Trisha Aure as she walks us through the highlights of our article 'FDA Announcement: 21 CFR 820 and ISO 13485 Guidance'

Hear the areas where 21 CFR 820 differs most from ISO 13485 and what this means for medical device OEMs. ​Part-2 of this series will cover the process to transition and key considerations when doing so.

Transcript:

​Travis: 
Welcome back to another MedTech Snapshot. Today's discussion we are continuing in the process as we look at the differences between 21 CFR 820 as well as the transition now for US based organizations into ISO 13485. 

So we had recently just discussed what the key differences were between those two standards. And joining me today is Square 1's Director of Operations, Trisha Aure. And she will plan to take us through what does that transition actually look like and what are some of the key things that we need to be aware of if your organization needs to make the transition from CFR to ISO. 

Trisha: 
Thank you, Travis, looking forward to this discussion. You know, as I, as companies are looking to do this transition to ISO 13485, I think one of the biggest things they need to start at is understanding what these changes are. So even if you are in compliance, I would suggest to do your due diligence. 

 And with that said, I think the first step is doing a gap assessment to prepare a plan on how and what needs to be implemented and change within your current QMS and in the existing document. And that's manuals, procedures and various work instructions. 

Travis: 
We got a comment from a someone on LinkedIn. I thought this was really good feedback. Maja Villarazza. 

 So I want to be clear in the comment here, this is she was not representing the FDA, but her feedback I thought was interesting, which is, you know, really looking at this transition and making sure from a, a change management perspective that you're adopting a, a phased implementation approach and really clear communication for management. And I know Trish, you're going to talk about that here in a second. 

Trisha: 
Yeah, You know, because I, I think with something so important like this, it's important to put various stages within your process to ensure the compliance aspect of it. 

And one of the things is doing an internal audit, and this is just for the verification. When there's a lot of changes that are happening, doing that audit confirms that things are being done appropriately and procedures are being followed. 

With that said, I think the training to the relevant personnel to ensure that these new processes and compliances are being understood and followed moving forward. This also helps with the continued improvement to ensure all of this compliance is being up, kept efficiently and effectively. 

Travis: 
I think that's key. The training piece is going to be really important because if people don't know or don't understand the bigger picture as it relates to why an organization is making the transition, we may find that some of our employees are not as bought in as what we would like to see or what we need them to be. So the training is a key piece. I appreciate that you brought that up. 

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