Updated in June 2025 with Formly's revised pricing model.
FormlyAI is an interesting eQMS software. Let me start by saying that the eQMS software space doesn't really see new products very often, so it's at exciting to see a new company entering this (very weird) market.
FormlyAI Company & Funding
FormlyAI is a small company and was founded by Spencer Todd and Severin Högl. Before founding FormlyAI, Spencer Todd was a medical device consultant, focusing on US FDA approvals, and Severin Högl was a Healthcare startup founder.
The company is located in the US. FormlyAI was founded in 2024 and is VC-funded, so it's not profitable at the time of writing.
Formly eQMS Software
Formly's main product is their eQMS software targeted towards medical device manufacturers going for EU MDR and/or FDA approval. In contrast to other eQMS providers, their software and pricing model has a few aspects which are noteworthy:
It has a lot of AI integrations: Their website showcases how the software can e.g. write drafts of your risk analysis.
Focused towards startups: Most other eQMS vendors cater towards larger companies because, frankly, they have more money to spend. Formly is probably one of the very few which cater towards startups.
In the past, I also noted that Formly offered a transparent pricing model which featured their subscription tiers (with prices) on their website. This, however, is no longer the case.
Additionally, I also noted that it was cool that Formly offers monthly billing. I cautiously assume that this is also no longer the case as Formly seems to have pivoted towards custom pricing for each customer, the typical B2B sales strategy where you have to "talk to sales", and those friendly people from "sales" try to extract as much money from you as possible (just my opinion).
In the past, their typical pricing as 899$ / month per product, which would usually result in a rather high price for most startups. I'm not sure whether this is still the case, but you can take a look at the current and past pricing further below.
Pricing
The FormlyAI pricing used to be transparent, but this is no longer the case. Their website now features these pricing "boxes":
FormlyAI pricing, updated around May 2025.
So, nowadays you're unfortunately left guessing what Formly's pricing might be for your company as you have to "Request a demo" first.
For reference, I've left the prior pricing below as it's possible that Formly's pricing internally might not have changed much, even though they don't expose these values externally any more. The most "common" tier in the old pricing model was the one for 899$ / product. And the main drawback of that was that you'd be billed per product, i.e. your price would double if your startup would go from your first to your second product.
Again, I'm not sure whether this sort of pricing model is still the current one, but it's interesting to keep in mind. If I had to guess, I'd say that they'll probably try to offer your company some sort of custom pricing.
I wrote a more in-depth article about FormlyAI's pricing here - if you're interested in some more details, check that out!
The prior FormlyAI pricing until around May 2025.
FormlyAI Drawbacks And Why I Wouldn't Choose Them
I've kept this review mostly balanced so far, but at the end, I'll cut to the chase: As of right now, I wouldn't choose FormlyAI due to some pretty huge yellow flags:
Their software is pretty much a copy of the OpenRegulatory Formwork eQMS: Yeah, this is our software 😂 it's somewhat funny to see the first company copy your website and eQMS software, but hey, this is how capitalism works and it keeps us on our toes, right? Regardless, it looks like they copied many things from us, even down to the website colors and phrasing in their marketing copy and product. Besides that, the big problem here is that their software simply less features than the "original". Also, it's more expensive and a more risky choice - see the next points.
It's a risky choice: FormlyAI was just founded recently. Medical device manufacturers (and even startups in this space) are generally very risk-averse. The #1 criterion for choosing eQMS software is whether companies will pass their medical device certification with this, and choosing any new software on the market carries a lot of risk here. Hell, even we've been on the market for ~5 years and sometimes companies choose software which is objectively worse than Formwork simply because other companies have been on the market for longer (10+ years). I can't blame them. It's a de-risking decision.
GDPR concerns: The company is located in the US. Taking into account the current geopolitical tensions around the US, it would make more sense to go with a European company. This would also improve your GDPR compliance situation. With their AI integrations, it's likely they'll be sending your data out to third-party providers located in the US, e.g. OpenAI, Anthropic, and others.
Pricing no longer transparent (as of 05/2025), likely no longer commitment-free: While FormlyAI published their pricing in the past, this is no longer the case and you'll have to request a demo and receive a custom quote. It's likely that they'll try to tailor the amount to your company so that they can make the most money off you. This is a real shame, because, historically, Formly started out by offering transparent pricing (with prices on their website!) and monthly cancellations.
High pricing: You can simply get better value for your money. Our eQMS software has been on the market for longer, more companies have passed certification with it (EU MDR and FDA!), and you're not limited by device count. Formwork also has a free tier and pricing models at 99€ and 499€ / month.
FormlyAI Conclusion
Don't get me wrong: It's cool that another company has entered the space of eQMS software for startups. Since Matrix Requirements was recently taken over my a Private Equity fund, this essentially only leaves users with our software, the OpenRegulatory Formwork eQMS.
So the conclusion of our FormlyAI review is this: Besides the fact that they copied most of our product, and from a purely rational standpoint, the question you have to ask yourself is this: Why pay more (899$ vs. 499€ / month) for a product which is more risky?
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Dr. Oliver Eidel
I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
