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.
- Monthly billing is available: In contrast to many other eQMS providers, FormlyAI provides a monthly billing option. Their 899$ / month model seems to be the most commonly selected one. Generally speaking, this is still a rather high price for eQMS software. They also offer other pricing options.
- 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.
Pricing
The benefit of FormlyAIs pricing is that it is transparent – their website shows their different pricing tiers, features and prices. There’s a free tier to get started. The most common tier is likely 899$ / month. You can choose a yearly option if you want to commit long-term and save some money.
Most importantly, FormlyAI bills you per product. This is an important distinction! The big benefit of this is that you essentially get unlimited user accounts and aren’t billed for additional “user seats”, something other eQMS providers love to do to squeeze more money out of you (ugh). However, the drawback of this pricing model is that your bill goes up very fast as soon as you consider launching a second, third or even fourth product. In my personal opinion, this is a pricing model which initially sounds great for startups, but becomes unattractive very fast once startups start scaling towards more products (and markets). Imagine that: Going from one product (899$ / month) to two products will double your eQMS bill (1,798$ / month). Ugh.
I wrote a more in-depth article about FormlyAI’s pricing here – if you’re interested in some more details, check that out!
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. - 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?
