QMSR Problems?

Darrin Carlson

Registered
Hi all,

Now that we have had a month to soak in the QMSR, how's everyone feeling about getting this implemented by February 2026?
  • What are your goals?
  • What are you worried about?
  • What barriers are you facing?
I'll go first. My organization is ISO 13485 certified, so this should be a relatively easy lift. My goal is to get a thorough line-by-line QSR vs. QMSR gap analysis this year.

I'm worried FDA investigators are going to be more exacting than a NB auditor (especially since they will be newer to ISO 13485), so I want to have all my ducks in a row and not rest on a general "no substantive impact" statement.

The only thing really standing in my way is finding all the time to get this comprehensive assessment in place!
 

Chrisx

Quite Involved in Discussions
We are also ISO 13485 certified, so it seems like a minimal lift, at least for now. FDA will update guidances, including the QSIT. When these come out, there may be more to do. For now, all I need to do is update our internal audit procedures and questionnaire. I probably won't even bother until much closer to February 2026, because in the mean time we will still need to comply with the QSR.
 

yodon

Leader
Super Moderator
The biggest epiphany for me was what was effectively removed - it would appear now that FDA inspectors *can* ask for internal audit and management review records.

But no major worries or barriers from our end (or for any of our customers we support).
 

LUFAN

Quite Involved in Discussions
The biggest epiphany for me was what was effectively removed - it would appear now that FDA inspectors *can* ask for internal audit and management review records.
For me, my biggest "worry" is not so much they can access the records which they kind of had second hand knowledge for some manufactures via MDSAP for a bit now, but what's the revised inspection approach going to say about following up on what's inside of them. I view that as proverbial low hanging fruit for tacking on other issues such as data integrity, trending, risk management tie ins, etc.
 

FRA 2 FDA

Involved In Discussions
Another Cover posted this in another thread. You may find this useful in your QMSR vs QSR gap analysis.
 

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Weeder

Involved In Discussions
Hi all,

Now that we have had a month to soak in the QMSR, how's everyone feeling about getting this implemented by February 2026?
  • What are your goals?
  • What are you worried about?
  • What barriers are you facing?
I'll go first. My organization is ISO 13485 certified, so this should be a relatively easy lift. My goal is to get a thorough line-by-line QSR vs. QMSR gap analysis this year.

I'm worried FDA investigators are going to be more exacting than a NB auditor (especially since they will be newer to ISO 13485), so I want to have all my ducks in a row and not rest on a general "no substantive impact" statement.

The only thing really standing in my way is finding all the time to get this comprehensive assessment in place!
That sounds like a good plan.

Although my organization is also ISO 13485 certified, my challenge is how to update the references in the QM and procedures (since there is no one-to-one correlation between the QSR and QMSR, or the QSR and ISO 13485). Hopefully, this does not mean a total restructuring of the QM.

Another challenge is to maintain parallel copies of documents, since the QSR will stay in force until February 2026 and in all likelihood the inspectors and auditors would not want to see them mixed together.

Training the employees will be challenging since they are used to terms like DMR, DHF and DHR and introducing new terms too early might confuse them. Training will have to be timed accordingly.

I also face the same problem of finding time to get the QMSR in place while trying to cope with the day-to-day QA/RA work. Starting early (now) and not waiting until next year is going to ease some of that burden.
 

jham65

Registered
Has anyone been able to determine how the new QMSR will handle Class I exempt products? Since the exemptions are determined by product classification established in sections 807 and 890 and they directly reference the old QSR sections, I cannot find anything on how this will look come February 2026.

For example, "Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files."

My ultimate question is will there be any exemptions to the new QMSR as there are in the current QSR?
 
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