QMS Refinement & Regulatory Submission
Learn how others have submitted their medical device products to governing bodies all over the world!
- 15 Topics
- 38 Replies
Two-part question:1) We have an FDA-cleared neonatal phototherapy device (Class II, 510(k) in 2019). We are in the process of launching a line of swaddling garments (not medical devices on their own) that can be used to comfort neonates in the NICU and/or in other areas of the hospital. As long as we are clearly not marketing the two together and the garment is not intended to be used with our phototherapy device, the two products can co-exist, correct?2) In the future we wish to explicitly market the two products together. We will have evidence to support claims that the garment supports and augments the performance of the phototherapy device, we will have established a DHF and other design control measures for the garment, and we would update our IFU for the phototherapy device. We are lead down the path of a new 510(k) due to changes in contraindications (source: FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device). Does the fact that we will have previ
Hi, I am working on a 510(k), which would introduce some machine learning models into the data processing pipeline of our software (which is part of a medical device, not SaMD). We did have a pre-sub meeting with the FDA, and they seemed to want a huge amount of details related to every possible aspect of the data collection and algorithm development. I am trying to write up the description now. I was wondering if anyone has successfully submitted a device that includes machine learning models and how it went. Is there any advice I could use to hopefully not get a million questions back from them after submission. Also, on a curiosity point, we opted not to submit with a Pre-Specified Change Control Plan, as that would have required us to use the De Novo pathways. Thanks for the help!Caitlin
1: If a medical device is working with a software,Is this software accepted as a device incorporating/utilising specific technologies/elements for this medical device?2: Is the medical device only in technical field of general active but not implantable medical device since this medical device cannot be operated without software? OR Is this medical device has 2 technical areas as general active but not implantable device and additionally device utilising software?3: Is the technical code for this medical deviceMD1301 Monitoring devices of non-vital physiological parameters? OR MD1301 Monitoring devices of non-vital physiological parameters with MDS 7010 - Medical devices incorporating software / utilising software / controlled by software?
During Sandra Rodriguez’ presentation, she said 53% of QA pros said that their QMS IS effective, while Management says that 87% said their QMS is NOT effective. Sandra didn’t claim to know why there was this discrepancy. Are you in the QA field? If so (or even if not) what is your opinion on this? Love to hear your thoughts!
HiA consultant told us that the state of the art section is the first thing that the auditor will look at in the clinical evaluation report, and if they feel that there is not sufficient substance or dont agree with the approach, that they may not review the file at all. Could you maybe do a talk on state of the art?
Hi all, I went through an ISO 13485:2016 audit in 2018 and an MDSAP audit in 2019.Some thoughts…(Hey @AlejandraB - FYI)We were going to do a combined audit, but we changed our minds. Why? We had a lot of changes to make to our QMS to go from our current 13485 version to the 2016 version due to our cert expiring and I felt like those changes were enough, without adding all of the MDSAP changes too. We needed to retrain the entire company to all of the new/changes docs in the QMS early enough to be able to create records before the audit. Part of the changes we made included a complete rewrite of our Internal Audit process and we needed to train internal/lead auditors to the new 13485:2016 spec and audit ourselves to the 2016 version before the audit. Part of the changes included an overhaul of the Management Review process and Quality Objectives, BIG things to change. We needed to improve our Customer Complaint Handling process. We improved how we collected, investigated, and manag
Does anyone in the community have recommendations for Inventory Management Software programs? We are looking for something that can help us maintain traceability of our materials through our receiving/manufacturing processes, and also help us track finished good movements from shipping to trunk stock, consignment, and customers. We are current evaluating a program called “Fishbowl” for this, but I figured I’d ask to see if any other programs standout. Thanks!
My understanding is that for devices like the Apple Watch, the app software that detects irregular heart rate is considered to be SaMD (software as a medical device) and is therefore subject to design controls. The question is, is the device itself covered by Design Controls? Is there a DHF for the physical components of these devices (such as the Apple Watch)? It would seem that the diagnostic ability of an app is only as good as the information that it is given, so I struggle to understand if a device is not held to the same standards as the software analyzing the data. Thanks!
I’ve heard some Regulatory experts say that they will push back on FDA on certain issues.One example I’ve heard... If a company changes their device and documents the change in a Letter to File, and then has another change, another Letter to File, and so on… Eventually they may file a “catch-up” 510k, using the special-510k. If the reviewer kicks it back on administrative reasons, some Regulatory experts will push back on FDA.When is it realistic/beneficial to push back on a regulatory agency? How do you make this determination, and then (once that determination is made) how can you execute this decision/pushing back without burning future bridges with FDA?
Certain software applications that medical device companies use aren’t required to be validated because they are low/no risk or don’t impact the product. Where do you recommend that these justifications for not requiring validation be listed? In the Master Validation Plan, in a separate memo, or somewhere else?
What are some of the most helpful Quality Objectives and KPIs your team has used to measure success during the premarket phase? I’ve seen success in setting objectives for fewer findings from Internal Audits, better on-time training completion, and fewer process deviations. What other premarket quality objectives and KPIs have you found to be successful?
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