Highlights
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2024-03-16 12:02 Just to be clear, I don’t think there were any particular problems with a quality system regulation, except that it was last updated in 1996. The major update to a quality system regulation in a major global market happened in 1996 when design controls were introduced. Okay. And that was around the time when 1345 was also emerging and evolving, and FDA had already been involved in the development of 1345. So actually, FDA’s position now is that they think ISO 1345 2016 version has sort of caught up with what FDA’s intent is in terms of regulating medical devices in the United States. So they feel like the timing is ready for them to officially harmonize and align with 13 485.
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2024-03-16 12:08 So one of the difference that we have in Europe and in us is the fact that in Europe we are using for getting this approval of the QMS. With ISO 1345, we have a certification body that is coming and verifying that. Yes, we are applying that, et cetera.
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2024-03-16 08:34 Working now, that’s a great question, Monir. So I want to separate the pre market versus post market. In the pre market phase, you have to follow FDA’s pre market requirements for 510 K’s PMs, right?
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2024-03-16 08:35 But that does not eliminate the need of an FDA inspection. And they will accept MDSAP.
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2024-03-16 08:36 Right now, FDA’s position is we’re going to be a part of 1345 revisions and conversations, which is basically telling me indirectly that we’re going to influence them to not change it significantly. In my opinion, 1345 2016 revision is an excellent framework for a risk based quality system, which is also utilizing the process based approach.
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2024-03-16 08:39 And one example of that would be like FDA used to require specific records, like DMR, DHF. Exactly. They are all going to be now part of your medical device file.
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2024-03-16 09:46 Okay. Manufacturers have time until then to update their quality management system to comply with the QMSR requirements.
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2024-03-16 09:48 In QSR, risk is explicitly mentioned only in one place, even though there’s a lot of discussion in the preamble which clarifies FDA’s expectations. But from a regulatory perspective, it’s mentioned only in one place.
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2024-03-16 09:50 What I want people to do is read FDA’s responses to comments and there were about 100 comments or so they have addressed.
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2024-03-16 09:51 But when we go to the 13 480 world, certainly the world is more around process based approach, which allows us to really evaluate the effectiveness of each of our quality management system processes, each of them.
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2024-03-16 09:53 In the context of 1345, we have to understand the scope of risk is broader than 14 971. Okay. 14 971 is primarily concerned with safety, even though they don’t explicitly say that.
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2024-03-16 09:54 Is it impacting performance, which, by the way, FDA calls safety and performance as safety and effectiveness. Okay. Yeah. So is it performing safety?
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2024-03-16 10:00 So Navin is really expert in risk management. He’s making a lot of content on risk management, mainly so he has his own channel for communication with also people.