Everything related to the development of medical devices & diagnostics
Hi everyone,I am Himang having 6 years of experience in the medical device industry with 3+ years of experience in medical device development and manufacturing environment. I have worked as Quality engineer in one company while as R&D Engineer in another but was not able to connect the dots between the two experience. I mean, how Design transfer occurs? What needs to be considered while transferring the prototype designed in the R&D into a commercial product ready for production? What are the documentation do we consider, and prepare to have a successful design transfer?The post is open for discussion, and their personal experience are highly appreciated. Thank you
Dear all, do you have experience with combined trial (where the object of the evaluation is 2 different products: a drug and a medical device)? Are 2 different protocols required? In which way the 2 submissions are linked and how the 2 different regulatory authorities communicate the outcome of the 2 applications, do we need 2 different approvals?Thank you very much,Silvia Ronchi
Hello, My name is Armando, a Lead Catheter developer with relevant experience in Class lll medical device development.Me as much as every developer, spend a lot of time trying to get inspirations on the web to solve complex catheter design challenges, and I have realized that its very rare to find any resources that help design engineers without a hefty price of a consultant which most of the time provides you with only general insights.That being said, and after finding out that there is no group at all for catheter designer to discuss ideas and challenges with fellow developers, I have decided to create a Linkedin group called “catheter engineer inspiration group”, I will try to post insightful resources and try answer group members challenges. Link to group: Catheter Inspiration GroupI am a passionate engineer who loves this field and would like to find more engineers who share this passion. Please feel free to join me in this mission :).
Hello, I am looking into trying to expand our labeling to include some clinical trial results so we can use them in marketing material. Is there a good guidance that explains the process for devices? Would I need to submit a full trial report for a labeling claim (rather than an efficacy claim)I have found the guidance for Acceptance of Clinical Data to support submissions Q&A, but was not sure if there was something better. Thank you for your help,Caitlin
I received an anonymous question and wondered if I could get some help! If I have a device currently marketed in the US and I want to start marketing in the EU, is clinical evidence that comes only from the US acceptable for notified bodies or does clinical evidence also need to include EU and/or other parts of the world?@joningib @Keith Kallmes @BenB are you able to help?
Thank you for the great participation in this weeks RoundTable on EUMDR Prep! Here are the links that were shared during the discussion - feel free to add to the thread if you have any additional comments or questions.https://greenlightguru.zoom.us/j/99110656160?pwd=Tm9PZUF3d2JveVl2dm01UXRMTDJxUT09https://greenlightguru.zoom.us/j/99110656160?pwd=Tm9PZUF3d2JveVl2dm01UXRMTDJxUT09https://leanraqa.com/free-guides/https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en Thanks again, @KarandeepBadwal, @BenB, @Michelle Lott, & @Brittani.Smith!
Community, With complaint handling training, is there a line beyond which you consider a supplier / contractor too removed to get training? For example, you may have a contractor with limited scope of on-demand services they provide to the manufacturer with very low likelihood of them ever becoming aware of a complaint. Is the manufacturer still required to train this individual / supplier? Looking for the least burdensome yet compliant approach here.
Often times early stage companies that have yet to establish a quality system are working with a contract manufacturing organization (CMO) that has a QMS. It can be a benefit to these early stage innovators that may have limited quality experience on their team to rely on the QMS of their CMO. What are the benefits and disadvantages of relying on the QMS of an eternal partner? Is there a good balance for how much to outsource versus establish in house?
I received an anonymous question, wondered if anyone can help here? We’re updating an MDD Technical File to MDR and the products from the previous technical file didn't have IFUs. They are class Is and IIa instruments and accessories. Originally, we supplied a symbols legend with these devices, but no instructions. I’m the "project manager" for this project and I have IFU development on my timeline, which has been questioned by my manager… They are saying that an IFU isn't needed for these devices. I responded with section 23.1 of the GSPR saying that medical devices entering the European Union under MDR must have an IFU, and he said nowhere in the MDR does it say that an IFU is required for class Is or IIa devices. At a previous company, we had a similar issue where we were putting together technical documentation for a group of accessories and these didn't have an IFU either and our European team had us develop IFUs from nothing, which was a huge pain. The class Is products are sim
Hello, do you have experience with LTD assay developed and used in the US to test samples from EU patients enrolled in a clinical trial?My understanding is that this is not “distance sales” (IVDR art. 5) because the assay is not used for remuneration in a commercial activity, but only for a clinical trial. And this is not an “in-house” test, because IVDR art. 6 applies only to EU laboratories.So, a LDT developed and used in the U, to test samples from EU citizens for a clinical trial, is not subjected to the IVDR requirements?Thanks for your advice.
Hi everyone.I posted this on LinkedIn earlier today. I thought you might find this interesting as well.The table below is an updated version of a table presented in ISO 14155:2020, Annex I. I felt there were a few descriptors and additions missing, so I created my own version.In my experience, people tend to only use "descriptors" when talking about medical device clinical activities - which can be confusing if you don't follow the same terminology standard.Descriptors can vary from one country, or regulatory environment, to another. But most importantly, descriptors are only one attribute of many️, used to describe a clinical activity. Only when all attributes are put together you can fully identify a clinical activity.The pilot stage is a good example, where people tend to use different descriptors for the same clinical activity.There are also a number of study designs that could be included in this table. But for the lack of more advanced design skills, and for the sake of my sanity
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!
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
Due to the pandemic and global supply shortages, more and more supplier audits have had to move to remote or “desktop” audits. Are companies losing anything when they perform a desktop audit in lieu of auditing the company in-person?If so, what do you think is lost? And if a company has no choice but to resort to a desktop audit when onboarding a supplier, how can that company mitigate what might be lost in a desktop audit vs. in-person?
It was brought to my attention that there is a new ISO standard on the horizon!ISO 10010: Quality management — Guidance to understand, evaluate and improve organizational quality culture. This is interesting because this is something that has been percolating my entire career.When I was in manufacturing, I was put in charge of a “continuous improvement” initiative. We put up a giant board in the shop area and asked people to post their continuous improvement ideas as “gems” (short for Gemba Keizen, and cut out in the shape of a gemstone - weren’t we clever??) If/when the ideas were instituted, the employee who submitted the idea got a spot bonus.I know, I know, there were several challenges… Who should do the work of actually implementing the ideas? How come they don’t get a spot bonus? What about people who don’t have time to get involved, or have a harder time coming up with creative solutions?We probably didn’t handle each of those questions 100% correctly… But the point is that we
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