Getting Started

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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

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How To Find Out Whether Your Regulatory Consultant Sucks

Anonymous

updated about 1 year ago

We’re working with a regulatory consultant but are not sure how capable they are. How to we find out whether our consultant sucks? And how do we identify good consultants?

Accepted answer

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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What's the Definition of a Medical Device According to the MDR?

Anonymous

updated about 1 year ago

What’s the definition of a medical device according to the MDR?

Accepted answer

Don’t expect a short answer when I’m about to cite regulations. Long Answer In the MDR article 2, section 1, it says: “medical device” means any ins

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Is Our Software a Medical Device (and Do We Need to Certify It)?

Anonymous

updated about 1 year ago

We’re a startup which is currently developing healthcare software. We’re wondering whether this software would be a medical device. That’s important because then we would need to get it certified befo

Accepted answer

It depends. Think about what your software does, consider writing this down (it’s called an intended use). Then, read the definition of a medical devi