Getting Started

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What happens after the Substantive Review and AI response in the traditional 510(k) process?

Anonymous • 1 comment

4 days ago

After the Substantive Review in the traditional 510(k) process, and after receiving and responding to the Additional Information (AI) request within the 180-day deadline, is the final 510(k) decision

Accepted answer

After you submit your response to the AI request, the FDA generally has 30 days to review it and make a decision. If they have additional questions, t

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Are there general authentication requirements for patient mobile applications under MDR?

Anonymous • 2 comments

12 days ago

Are there any general guidelines or requirements under the Medical Device Regulation (MDR) for authentication in patient-facing mobile applications? I am specifically interested in requirements that w

Accepted answer

Overall, MDR does not specify detailed authentication requirements for patient mobile applications. The MDCG cybersecurity guidance mainly suggests us

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Should we send all our developers to multi-day 8-hour "training sessions" for e.g. the ISO 13485?

Anonymous

16 days ago

Our CEO thinks that "quality is really important" and that "we need to show our investors and customers how much we value quality and safety", and has therefore sent everyone in the company to attend

Short answer: No, none of this makes sense. Your two most likely options are: • Convince the CEO that this is a huge mistake, save the company, and st

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When Should We Start Documenting Our Medical Device And QMS?

Anonymous

updated 9 months ago

We are currently developing our software medical device and might be done in 6 months or so. We want to get started with documenting it right now! What can we do?

Accepted answer

If your software is not done yet, the most efficient approach in 95% of cases is to wait until your first version is done. For some reason, most peopl

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Which Notified Body Should We Choose?

Anonymous

updated 10 months ago

Which Notified Body should we choose?

Accepted answer

DQS, BerlinCert, or maybe one of the lesser-known ones in Eastern Europe, in that order. Avoid BSI and Tüv Süd. Subjective opinion. Long Answer Discl

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Do We Have to Read Those Boring Standards?

Anonymous

updated about 1 year ago

We’re in the early stages of founding our company and developing our product. We’re wondering what it takes to certify our software as a medical device. We’ve heard about all these standards we’d have

Accepted answer

Yes. Read the standards. Long Answer Some founders ask me whether they have to read the boring standards, e.g. the ISO 13485 (quick note: here's our

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Should You Do a BfArM Classification Request? The Answer Is No.

Anonymous

updated about 1 year ago

We have no clue how to classify our medical device under the MDR. It could be class I, so we won’t have a notified body. Is there anyone who could give us a final decision? Our company is located in G

Accepted answer

If you think your device is a MDR class I device, you have three options: • Just bring it to market and wait for a surprise audit by the (state) co

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As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?

Anonymous

updated about 1 year ago

We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and checked out the list of MDR class I devices on this website and it seems that MDR class I softwa

Accepted answer

Yes, probably. Long Answer Some quick background information first! (By the way, if you're interested in a summary of MDR class I in general, check

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MDR Class 1 Devices: Do They Exist (as software)?

Anonymous

updated about 1 year ago

I’ve heard that, under the MDR, software is usually classified as class IIa device or even higher. In the past, under the MDD, many software devices were classified only as class I. That made regulato

Accepted answer

Yes. Two examples come to mind: Software for the (primary) prevention of disease, and software for directly treating a disease. It boils down to readi

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Can We Document Our Software After We've Developed It?

Anonymous

updated about 1 year ago

We want to certify our software as a medical device, but we've already developed parts of it (or all of it). Do we have to re-do our entire development, creating "compliant" documentation along the wa

Accepted answer

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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Should We Use Short Or Lengthy Templates For Medical Device Compliance?

Anonymous

updated about 1 year ago

We're a startup and currently looking for document templates for our medical device compliance. The OpenRegulatory templates seem to be rather "minimalistic" as they appear rather short. Other consult

Accepted answer

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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How Much Does Medical Device Compliance Cost?

Anonymous

updated about 1 year ago

We're a startup and are considering bringing a medical device to market. How much does it cost?

Accepted answer

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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Should We Register Our Algorithm As a Patent?

Anonymous

updated about 1 year ago

We’re developing software. Should we patent our algorithm?

Accepted answer

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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Can We Bring a Lifestyle Device to Market First?

Anonymous

updated about 1 year ago

We’re developing software as a medical device which might be class I or IIa under the MDR. Right now, we don’t want to go through all the regulatory pain and are wondering whether we can bring it to m

Accepted answer

Yes! With some limitations though. The most important one is that the product which you bring to market must not fulfil the definition of a medical d

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Should We Develop Our Software Or Set Up Our QMS First?

Anonymous

updated about 1 year ago

We’ve just started developing software which will be a medical device. Some consultants now told us that it’s important to set up our Quality Management System (QMS) first before we continue developin

Accepted answer

Develop your software first. We are the only consultants with this opinion (other consultants disagree heavily). But then again, we seem to be the onl

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How Long Does Medical Device Compliance Take?

Anonymous

updated about 1 year ago

We're a startup and want to bring a medical device to market. How long does it take to get all the medical device compliance done, e.g. for a software device?

Accepted answer

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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How To Do Medical Device Software Development?

Anonymous

updated about 1 year ago

Our company wants to get into medical device software development. How do we get started and how do we have to change our existing software development processes?

Accepted answer

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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Do We Need AI / Machine Learning Consultants?

Anonymous

updated about 1 year ago

We want to develop a medical device which is based on an AI model. We’ve recently been approached by consultants who specialize in the field of medical devices and AI / Machine Learning / Deep Learnin

Accepted answer

Hell no! The medical device consultant industry is shady as hell, and medical device machine learning consultants are no exception. I have indirectl

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Should We Choose Our Cloud Provider Based on Free Credits?

Anonymous

updated about 1 year ago

Our startup is part of an incubator and we’ve been approached by a cloud provider which offered us a few thousand Euros in free credits if we go with their platform. Should we do it?

Accepted answer

No. Choose whatever cloud provider is the most suitable for you on a technical level. Most commonly, that’s not the provider that throws around free c

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How Do We Certify API-Only Software As a Medical Device?

Anonymous

updated about 1 year ago

Our software only provides an API. We think it’s a medical device. How do we get it certified?

Accepted answer

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