ISO 13485 Audit Passed
MDD Class I Device Shipped
MDD Class IIb Device Certified
Your Situation
You're a small team. You mainly have an idea, but you haven't developed your product yet. Now, you need to plan the next steps: How much time and money will you allocate for regulatory work? Will you need to hire someone? You'll need answers to those questions before approaching your investors.
Here's what we typically tell companies at this stage:
Don't stress out about compliance work. You're in a startup, and startup founders have lots of other problems on their plate! Like getting funding, developing the right product, assembling a team, etc.
The most efficient way to get your product certified is to document it when it's mostly done.
However, there might be a few important things you should keep in mind before you move forward with product development. Let's get together one afternoon and come up with a plan.
This is not our first time.
We've worked with over 40 companies. Here are some.
ISO 13485 Audit Passed
MDD Class I Device Shipped
MDD Class IIb Device Certified
We'll get together for an afternoon to figure out a regulatory strategy for you.
What does that mean? First, we need to determine your Medical Device Class. Maybe we'll be able to come up with a few changes to your product which enable you to be in a lower class which hugely reduces regulatory work!
After that, we'll sketch out what the next steps for your timeline would be and how long it would take you to get it certified.
And finally, we'll help you choose the right cloud providers, regulatory software (e.g. Google Drive, GitLab, Formwork) and help you hire the right people.
How do other consultants do it?
Most other consultants will try to make you scared of regulatory work, like - oh my god, it's so much! It'll take 12 months! - and then they'll try to sell you expensive workshops and consulting hours for setting up your documentation because you need to document everything during development!
We think this is detached from reality (and expensive). Working at a startup means that the product may change multiple times during its development. Does it make sense to create documentation for your product if you end up trashing it as soon as your product changes?
Also: If you're a five-person startup, will a Quality Management System really increase quality, or only add overhead? Agile development is about people, not processes.
If you request offers from other consultants, ask them about their experience. Have they worked at a startup? Have they written software themselves?
1.400€ for an afternoon.
From our experience, our prices are at least 50% cheaper than other consultants.
How do other consultants do it?
Most other consultants charge at at least 3.000€ for this. Their workshops are often very abstract - like when someone reads the regulations to you.
They will shy away from giving you real anwers to your hard questions. Like, how do you document software requirements? How can we use GitLab for compliance?
Develop your product, dude! Come back when you're done.
Once your product is mostly done (or you at least know when that'll be the case), have a look at our three-step fixed-price offer for creating all required documentation.
How do other consultants do it?
Other consultants will schedule weekly eight-hour meetings with you to set up the Quality Management System.
Your development speed will slow down to a crawl while your software developers start hating you because now they're filling out forms in Microsoft Word instead of writing code.
Sure. We offer a starter package which consists of these things:
An afternoon workshop (same as above).
Access to our videos for up to 5 people.
Access to our regulatory software, Formwork, for a year.
And 12 consulting hours to answer your questions every few weeks.
All of that for 6.500€. It's a pretty sweet deal.
But, that being said, it's not a must-have. Again, develop your product first! Then, go on a walk. After that, pet your dog. Only then, come back to us and ask about our starter package.
How do other consultants do it?
Other consultants don't have a starter package.
Ready to get started?
Send us an email or schedule a call - it's free!
Which other compliance requirements should we keep in mind?
Don't forget GDPR compliance. As soon as you're processing personal health data, you need a Data Protection Officer (DPO). You can even hire us as external DPOs as we're qualified to do just that - feel free to get in touch!
Any other compliance requirements for Germany?
If you're planning on certifying your Medical Device as DiGA (reimbursable app) in Germany, there are some additional data privacy and IT security requirements. Most importantly, you can't use US cloud providers. So it could make sense to build your software in a way in which it's not coupled to specific cloud products (e.g. AWS Lambda). That way you could run it on any virtual server (e.g. Hetzner).
Once our product is nearly done, how much would it cost to hire you?
Around 25k€ if your product is MDR class I, around 50-80k€ if it's MDR class IIa/b.
And how long will that take?
4-12 weeks, depending on how much time you yourself spend on creating document drafts.
Should we hire a regulatory person?
Probably not right now, but if your device will be MDR class IIa, then yes, you'll need to hire a full-time person for your regulatory work.
Should we already get in touch with Notified Bodies?
Yes, that can make sense because Notified Bodies are chronically overbooked with long wait times. However, you should be sure about what sort of product you'll be developing and you need a clear timeline for when you'll be done. Also, your company must be founded. If all of those things are fulfilled, yep, you could get in touch with a Notified Body. But maybe talk to us first.
Can someone confirm the MDR class of our software?
If you're class I, the short answer is no. If you're class IIa, yes, your Notified Body can do that. Before that, we can come up with a pretty good assessment.
How much does an audit by a Notified Body cost?
Typically 30-40k€.
Ready to get started?
Send us an email or schedule a call - it's free!