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Annex I, 23.4. Information in the instructions for use(z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is establishedIs actual practice and expectation to include a canned statement to this effect in every IFU?
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
Some people just have more guts than I do. Steve Gompertz carried his tri-fold-sized Quality Manual into an FDA inspection, and you know what the inspector said? Check out the video - I’ll let Steve tell the story. Steve has a TON of experience in this field, and loves to help companies implement lean Quality Management Systems. P.S. If you want to skip Steve and my chitchat, skip ahead to the 10-minute mark - we were recording from the get-go!
Hey everybody!My name is Tim Hickle and I’m our Director of Content and Community here at Greenlight Guru. You are going to see me from time-to-time sharing content and sharing moderating duties with our world-class Community Manager, Etienne.I wanted to start a thread where we can introduce ourselves and share the human side of our community.A little about me: I’m a born-and-raised Hoosier (That means “Person from Indiana” for those of you not from the States) who loves basketball and a good nonfiction book. When I’m not working or parenting, you’re likely to find me listening to a podcast or watching Ted Lasso. My wife is named Kristen and we have an almost-two-year-old named Myles who is NOT the most efficient co-worker I have, but who is definitely my favorite. Feel free to share a little bit about yourself, your interests, hobbies, and family! Whatever makes you, “you!”
Between Product Development and Quality Assurance, there are a few tasks related to Design Controls that are done by… Design Assurance. Whether or not they where the title, the functional owner of most Design Controls tasks need to be able to toggle between Product Development and Quality - it’s a unique hat (or set of hats) to wear. We hope this discussion is helpful as you approach the Roles and Responsibilities of someone working in Design Assurance! Thanks,@Etienne
RoundTable on Clinical AffairsWhat are the things you're struggling with when it comes to clinical affairs and your device? What aspects of this topic would you love to hear the industry experts dive deeper on? Let us know in the comments below and we’ll make sure it’s mentioned!Make sure you RSVP to our live RoundTable discussion on Sept. 28th!
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
Let’s talk packaging & sterilization! I don’t know about you, but this is one of those topics that some manufacturing and product development engineers try to push to the bottom of their priority list, and “kick the can down the road” until they absolutely HAVE to address it. Which can quickly turn into an “all hands on-deck” situation.Instead of putting it off, let’s talk about all your packaging and sterilization questions.EDIT: I just found out that Roy (our expert) will be unable to make it, and with the Virtual Summit going on right now I’m not able to get a back up expert on Packing and Sterilization… SO! If you still have specific questions, please drop them in the comments below, and I will make sure they are answered by the end of the week!Thank you for your patience and especially your participation!All the best,Etienne Nichols
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