Your Situation

You're in the middle of developing your product. You've got a timeline, funding, and your company has already hired a few people. Now you need help in getting the regulatory work done so that you can get your product certified.

Here's how we typically solve it:

We'll help you with project management and set up a plan which contains all documents you need to create, in the right order.

One or two of your employees will learn how to fill out those documents with our videos, and we'll support you in getting your documentation done through weekly meetings and reviews.

That's it. Then we're done.

For a fixed price - no hourly billing.

This is not our first time.

We've worked with over 40 companies. Here are some.

ISO 13485 Audit Passed

Oliver was brought in to help Ada Health in certifying their Quality Management System based on ISO 13485. They successfully passed the audit by a Notified Body in June 2020.

MDD Class I Device Shipped

Exakt Health set its goal to ship its innovative, physiotherapy-at-home app before the MDD deadline in May 2021. We helped Philip, their CEO, achieve this goal and bring their app to market as a medical device - before the deadline.

MDD Class IIb Device Certified

Vara was Sven's and Oliver's past startup which developed a machine learning - based software for breast cancer screening. Together with the team, we passed the ISO 13485 audit and got the product certified as class IIb medical device under MDD.

How Does It Work?

It's a simple three-step process. Here are the steps.

Step 1

Scoping and Offer

We get together for an afternoon to understand your product and how much time you have to create documentation. After that, we send you a fixed-price offer.

Step 2

Create Document Drafts

You'll get access to our videos. With those, you'll be able to create first drafts of your documentation. If you don't have much time, we can help you with that.

Step 3

Review Documents and Finalize

We'll review your documents together to make sure they're complete. You'll also have lots of questions. Typically, we do all of this in weekly meetings. Once all documents are done, we're done!

How do other consultants do it?

Most other consultants don't have a clear plan. They won't provide you with a step-by-step list of documents which you need to create. If they don't use videos, they'll try to teach you stuff in hour-long workshops. If they have videos, those are often abstract and don't show you how to fill out documents.

If you request offers from other consultants, ask them for a plan with a clear timeline. If they have videos, look at some free samples. After watching those videos, ask yourself: Are you ready to fill out your own documents now?

Some consultants may offer to fill out all documents for you. That's not a sustainable approach because it'll be you sitting in audits and maintaining them.

How Much Does It Cost?

Around 50-80k€ for MDR class IIa/b devices.

MDR class I or IVD self-declared devices are around 25k€.

We only make fixed-price offers because that's the only fair way of incentivizing us: You pay when stuff gets done, and you know exactly what it's going to cost.

The final price depends on your product complexity and how much time you're willing to spend on creating documents yourself. If you do more, the price goes down.

From our experience, our prices are at least 50% cheaper than other consultants.

How do other consultants do it?

Most other consultants prefer to bill by the hour - or even by the day. They will give you a daily rate which ranges anywhere between 1.200€ and 2.400€ and a (very) rough estimate of how many days it will take them.

This will heavily incentivize them to bill a lot of time. And how do you bill a lot of time? By doing long workshops and creating hugely complex documents which take (you guessed it) even more time to maintain. That's the exact opposite of what a startup needs!

Additionally, you have absolutely no guarantee that the project will be done on time.

How Long Does It Take?

Around 4-12 weeks.

What's the bottleneck? It mostly depends on how much time you have for creating drafts of documents and working on our reviews

In a best-case scenario in which someone from your company does this full-time (at least temporarily), we can be done in 4 weeks. It'll take longer if you do it part-time.

How do other consultants do it?

Most other consultants don't provide clear timelines.

Some say "it takes very long to set up a QMS" and estimate 6 to 12 months. Six to twelve months!

That's precious time you could spend on building your product. And you should.

Ready to get started?

Send us an email or schedule a call - it's free!

Frequently Asked Questions

You said it takes 4-12 weeks. We're on a tight timeline. How can we speed things up?

We can help you draft documents. That'll cost you more and be less sustainable for your company (it'll be harder to maintain your documents), but in the context of tight deadlines (e.g. investors) it can make sense.

Can you recommend an eQMS software?

We might be a bit biased here as we have our own QMS software.. chuckle. It's called Formwork and we use it internally. It's really cool because it saves you a ton of time. Happy to show it to you. But feel free to use any other software! Google Drive, GitLab and Confluence also work. The only thing you as a startup should avoid are enterprise-y software and their shady pricing models.

Is there any chance of becoming MDR class I?

I could give you a long answer, but the truth is, nobody knows currently. Based on guidance documents, MDR class I software doesn't really exist, except for fertility planning apps (don't ask). In reality, I've heard of auditors applying a wider class I definition if it's e.g. a patient-facing app with a low risk profile.

What about the Clinical Evaluation?

We currently don't write Clinical Evaluations because it's a huge pain. Also, with the MDR, people currently don't know what sort of clinical data you need. The consensus seems to be that you commonly don't need a clinical study. But we'll lean back and see how this plays out once more companies have gone through MDR audits.

Do you also provide support for DiGA certifications?

No, sorry. The DiGA field unfortunately also has quite a few shady consultants. You may not even need one. The BfArM has provided some pretty good documentation and checklists. Read through those and see how far you get.

Do you also provide support for ISO 27001 certifications?

Nope, sorry. Maybe in the future.

How do we make changes to our product once it's certified?

It depends on your class! If it's self-declared (MDD/MDR class I or other IVD), the simple answer is that you're only allowed to make changes if they're not "significant" (a whole other topic). If you're class IIa/b with a Notified body, you're allowed to make those changes but need their prior approval first (which costs money, again).

Do you recommend a specific Notified Body?

We're happy to talk about our experience with different Notified Bodies during a call! And then your decision should be easier :) but, for now, we won't write about it. Some time in the future, for sure.

When should we choose another consultant instead of you?

Good question! If you're a hardware medical device, you probably shouldn't work with us as our experience only includes software. Also, if you need to do a clinical study, we're pretty clueless. So those are good reasons. But don't fall into the trap of choosing another consultant due to their "connections" to e.g. Notified Bodies - I've never seen this end well.

What about data privacy / GDPR compliance?

We actually also offer help there! Our colleague Sven has quite a lot of GDPR experience and all of us are qualified Data Protection Officers (DPOs). We can pretty much set up your entire documentation and also be your external DPO afterwards.

We don't have a MDR Person Responsible for Regulatory Compliance (PRRC). Can you provide that?

Yes! But we'll need to look at your product and documentation first because we'll be responsible. If you've worked with us in the past, that's not required, of course.

Ready to get started?

Send us an email or schedule a call - it's free!

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