![]() Or, if you're looking for some human help, did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?Īnd there's so much more: If you're looking for the best QMS software ever, look no further.I was a juggler on a tightrope balancing over a pool of crocodiles. It's a self-guided software which helps you create your documentation yourself, for only 149€ / month. On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. Hopefully I’ll have a template for this in the future :) Then you’ll know what your next regulatory steps should be. As soon as you have a rough idea of what you want to develop, write itĭown. Question “Is our software a medical device”? Intended Use: Write It Now non-medical software, check out my answer for the To get an idea for the differences between medical vs. If your companyįails, you don’t have to bother with regulatory compliance anyway. ![]() RegulatoryĬompliance and patient safety are very important, but shouldn’t detract you from those goals. ![]() Your main goal should be developing your product, getting customer feedback and gathering revenue. That’s hardly possible when developing software as a medical device. Facebook was (and is) not a medical device - that’s why they could get away with Most consultants won’t tell you this: The best way to achieve regulatory compliance is to not have a medicalĭevice in the first place. It ultimately decides whether you have a medicalĭevice in the first place and what your next steps are based on itsĪnd maybe you’ll notice that it’s not even a medical device at all? Is It Even a Medical Device? The importance of your intended use can not be overstated. ![]() Your software is “only” a medical device, not an IVD. Principle and method of data analysis (what do you do with those samples?). tissue samples from a specific organ) and describe your test Where the analyzed samples originate (e.g. Then, in your intended use, you additionally have to specify from Which operates not on patients, but on lab samples (tissue samples etc.), then you’re not a medical device,īut an In-Vitro Diagnostic Device (IVD). If you’re developing something like a lab test or software on a hospital ward? In anĮmergency room? On workstations? Is it pre-installed on those workstations or is it a web-basedĪpplication? Is it an app? If so, how and when is this app typically used? Are any specific lightingĬonditions necessary, like for looking at x-ray images (in dark rooms)?Īnd then there’s another, rather unlikely scenario. Usage Context: Describe in which setting your software is used.Users: Characterize the users who will be using your software, e.g.how does this software diagnose / treat / monitor Medical Purpose: What makes this a medical device (as per the MDRĭefinition)? E.g.These are the sections you should typically cover: So how do you write an intended use? Easy. The lower your class is, the less effort and cost is What class of medical device (I through III) it is. Why is that so important? Because it decides whether you are a medical device in the first place, and if so, Why? It states what your software does and in which context it is used. The Intended Use is the most important document, ever, if you want to certify your software as a medicalĭevice. Writing An Intended Use for Software as a Medical Device Dr.
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