How Long Does Medical Device Compliance Take?


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?

Short 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 class I, but with an additional 3-9 months wait time for audits by a so-called Notified body.

Long Answer

This is probably the #1 question asked by all startups I talk to. And, somewhat surprisingly, other consultants seem to be completely incapable of answering this question. Maybe because they bill by the hour, which motivates them to, well, bill many hours. So it wouldn’t be a great customer experience if they blurt out “yeah I’ll string you along for 12+ months as a consulting customer so that I can bill a sweet amount of hours for many months”. There, I said it.

Anyway, back to topic. First off, it’s important to differentiate two things:

  • Work which you need to do which is in your control. In simple terms, this is about creating documentation – a bit like writing a Bachelor’s thesis, just much more boring. It’s completely in your control.
  • Work for which you are dependent on other people (auditors). This is mostly outside of your control – like when you hand in your Bachelor’s thesis, you’re dependent on some random University dude grading it and reporting that back to you. Same with auditors. You need a so-called Notified Body which is a for-profit company (don’t ask) which audits medical device companies like yours.

How Long Does The Work Take?

With those two things in mind, I can tell you how long each of them take:

The work which you need to do takes around 2-3 months if your company is very capable (more on that later) and if you choose a lean approach (more on that later, too). Many companies screw up here and take 12+ months which is beyond crazy.

The work for which you are dependent on auditors takes anywhere between 3-9 months (if you’re unlucky, even longer).

With those figures in mind, it’s easy to calculate the total duration you need for each medical device class, because not every medical device class needs audits, i.e. for one particular class, you can get it done in 2-3 months! That’s MDR class I.

How Does Medical Device Compliance Take – Dependent On MDR Device Class

MDR ClassDuration (your work)Duration (audits)Total duration
I2-3 months (lean)
12+ months (clunky)
None required!2-3 months (lean)
12+ months (clunky)
IIa, IIb2-3 months (lean)
12+ months (clunky)
3-9 months~12 months (lean)
~24 months (clunky)

By the way, if you’re wondering where class III is on that table, I didn’t include it because it takes even longer, you shouldn’t do it, because you’ll likely run out of money and be screwed. Also, I have no consulting experience for class III devices.

Anyway, you can see that there’s a significant difference between the “lean” and “clunky” approach. Personally, I think this is by far the biggest difference between startups which get medical device compliance done well and startups which screw things up big time. It’s probably your most important strategic decision regarding compliance. Let’s look at that next.

What’s The Difference Between The “Lean” And “Clunky” Approach?

Over-Engineered Templates!

Some quick background: For medical device compliance, you have to fill out a ton of documents, and you typically do that by purchasing document templates from other consultants (shady!) or use our free templates (much better!).

Now let me give you two figures. The first figure is about the length of templates.

Here’s the typical page count of our templates vs. templates of other consultants regarding software development, risk management and usability evaluation.

If you use our free template, it includes everything (software development + risk management + usability engineering), and it’s approximately 5 pages long. That means you have to read through 5 pages, adapt them to your company and product, and you’re done.

If you use templates of other consultants, the first problem is that they usually have multiple templates for this: One for software development, one for risk management, and one for usability engineering. That means you have to fill out three documents. But the next problem is that they’re much longer, too! The one for software development might be 30 pages, the one for risk management 10 pages and the one for usability engineering another 10 pages. That’s 50 pages in total!

Now, what would you prefer to do as a startup founder – fill out 50 pages or 5? I’d go for 5. This represents a 9x efficiency gain!

Now your typical reaction might be: “But will auditors accept those short templates?” – good question, Jedi, and the answer is yes, because in the past 5 years since we’re around, many startups have passed audits with our templates and Notified Bodies even already know (and appreciate!) our templates.

So this is the first aspect where you’ll lose time if you choose other templates.

Let me drill that point down again, because I still see founders make the wrong decision. Here’s a handy table:

Template TypeTotal Page CountCostPasses Audits
OpenRegulatory Templates1xFreeYes
Other Consultants Templates~9x of OpenRegulatory Templatesx,xxx €Yes

Okay, so you have a template option which is free instead of costing a four-digit sum, it passes audits, and it gives you an 9x efficiency gain. If you still go for other templates now, then.. well, if your startup runs out of time and money, don’t come running to me so that I clean up your documentation mess.

Talking about choosing the wrong consultants – that’s my next point.

Over-Engineering Consultants!

The next wrong decision which startups make is hiring the wrong consultants.

First off, let me be clear that you actually don’t need consultants. It’s our goal to share as much for free as we possibly can on OpenRegulatory, so, best case, you just take our free templates and read articles (like this one) and get everything done yourself.

Still, consultants do have a place, for now, I guess, until our content here is truly complete (then I can retire! How will I make money though? I don’t know!). The main benefit of bringing in consultants like us is that we help you fill out the templates by reviewing what you drafted, we help you write stuff if you get stuff and we do some project management to tell you what to tackle next.

That last point is the most important. You need consultants who are very well-organised, i.e. people where you walk away from calls with more answers than questions, and and people who are incentivised the right way, i.e. only getting paid when results get done (not by the hour!). I wrote a separate post on choosing the right consultants, check it out.

Incapable Team Members

The third problem is hiring regulatory people for your regulatory position. I don’t know why, but I’ve seen startups succeed far more often if they’d hire a smart person willing to learn regulation instead of a senior regulatory person. Maybe senior regulatory people are weird, or maybe smart people willing to learn new stuff are just more pragmatic and fast. Separate article here.


And that’s it! In summary, choose lean templates, don’t hire crappy consultants, get a smart person in your team on the job and you’ll be on the market faster than your competitors. And if you are interesting in our consulting (again, you might not need it), check it out here!

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. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.


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