Questions

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Don't do it, it doesn't make sense. Long Answer You're probably looking at eQMS software right now and are wondering which one of them integrates wel

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Don't worry, young Padawan. You can document your software after you've developed it. This works for your first software version, i.e. the first medi

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Choose the minimalistic ones. You goal is to pass your audit in the most efficient way possible. In the history of this planet, no company has ever r

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MDR class I: Free, if you do it yourself (recommended). MDR class IIa and higher: At least 30k€, probably 50k€. Both figures increase if you hire co

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If you're MDR class I: 2-3 months with our approach, or 12+ months with other consultants / templates. If you're MDR class IIa and higher: Same as cl

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If you don't have any prior regulatory experience: Don't look for QMS software right now. Instead, learn more about what you need to do (read articles

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No. Long Answer Ah yes, agile development of medical device software, the million dollar question and a question where every regulatory consultant se

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You don't have to change anything, but you now have to do tons of documentation. Other consultants typically have a very different opinion on this and

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No. If you want to get your technical documentation done fast, doing other things will give you much more leverage. Long Answer Ahh yes, I get this q

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Read my ultimate guidance on PMS and my article about trend analysis. Long Answer Let's start with the regulatory background. I know it’s boring, but

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No. Focus on marketing (finding customers), sales (making money) and improving your product (for more customers and more money). Long Answer Ahh. A c

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If you need clinical data depends on your intended purpose (and the opinion of the auditor), the novelty of your device and yes, you can write of that

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Ah, glad you ask. This is a great question! Solving this will save you a lot of time and money, because crappy consultants cost a lot of time and mone

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Summarize all your clinical studies you conducted as well as all planned studies and investigation for your device. Provide a justification if you thi

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No need to hire a statistician. Structure the complaints, plot them over time and describe what you see. Long Answer According to the MDR, Article 88

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If your API will be integrated into another medical device, there might be a chance that you don’t need to certify it at all. However, there are API

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There’s no such thing as “21 CFR Part 820” compliance or certification. Only the content matters - i.e., the documents you create. You could create th

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At minimum, between five and fifteen. Long Answer If you just got started by reading some regulation, your disillusioned self will assume that someth

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A Unique Device Identifier (UDI) is a distinctive code assigned to medical devices (and their packaging) to provide them with a unique identity. Simil

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IFA is a three-letter powerhouse that sounds more like a football association, but it is actually a global manager of product data. IFA stands for “In