Summary:
Scarlet brings a modern, pragmatic approach to SaMD regulation that meaningfully reduces friction for fast-moving software and AI teams.

Overall impression:
It’s refreshing to work with a notified body whose mission is to enable the next generation of medical technology, rather than forcing modern AI and software into last-generation regulatory frameworks. Scarlet’s approach maintains clear regulatory boundaries while actively modernising how assessments are conducted.

Scarlet ask me to leave a review, but I took the time because I think they are great, I want them to succeed and I think they will shape the future of the industry, directly or indirectly. I have not been paid or in anyway incentivised to leave a review; I'm just a big fan.

Scarlet are our notified body and did our ISO 13485 certification, and our certification for a complex class IIa AI device under EU MDR. I'd strongly recommend any SaMD device to use them as their notified body. I've previously worked with a handful of the older NBs - BSI, UL, TUV etc and working with Scarlet has been a radically better experience. 

They move much much faster than a standard notified body, and their submission platform and processes are evolving all the time to further add efficiency (e.g. older reviews below re GitHub structure and skills requirements no longer apply to the latest submission platform). Their responsiveness is also on a totally different level to the other NBs I've worked with - with Scarlet it's common to get responses to queries within minutes, where incumbents would often take days. 

The benefits of specific software focus and expertise in a NB also became very apparent to us during the process. Being specifically dedicated to software devices mean that their team and processes are designed around software clearances, and their assessors have far greater (and modern) technical backgrounds in software than you'll get with anyone else on the market. 

All of this means that your initial device clearance will be a faster, better experience with Scarlet, but then the big advantage is actually post-clearance. Their whole approach is built around making device updates (including substantial changes) as efficient as possible. Historically this has always been the biggest frustration with SaMD and older notified bodies - manufacturers end up only being able to ship meaningful updates to their device a couple of times a year because of the regulatory process and cost burden. By streamlining these processes and wrapping it all into a subscription model, Scarlet have now made it possible to release far more frequent updates, which ultimately means our product gets better faster, and patients can always benefit from the best possible version of the device. 

Because of this point, I would actually disagree with the openregulatory summary above relating to the subscription model. For us the subscription model has actually been a better pricing approach than the old-fashioned fee per hour/submission approach. This is partly because it gives us much greater predictability over our regulatory spend, but also because it means we're able to ship updates frequently without cost being a factor or barrier in that decision. As a result its not uncommon for us to make updates to our SaMD on a monthly or even fortnightly basis, and I don't believe there is currently any other NB who could facilitate anything close to that sort of release cadence!

Scarlet is a start-up Notified Body that, despite some early teething issues, has impressed us with its responsiveness and the expertise of its QMS and technical reviewers.

Having previously worked with several larger Notified Bodies, it's been refreshing to engage with a team that demonstrates genuine interest in our technology and maintains excellent communication throughout the review process. 

Their submission platform is relatively complex and best suited to teams with strong software capabilities. However, we’ve already seen encouraging signs that significant usability improvements are on the horizon to make it easier to submit documentation.

Scarlet are not the lowest cost provider out there, but we've been happy to see that device change and PSUR reviews are included in the monthly price, making regulatory budgeting more predictable. 

Overall, highly recommended. 

Scarlet Pros

1. Modern Communication: Young, tech-savvy team uses tools like shared Slack channel for communication.
2. Innovative Submission Process: Uses GitHub and markdown files instead of traditional PDF/Excel documents.
3. Structured Guidance: Atomic forms provide clear expectations and reduce ambiguity.
4. Remote Audits: Less time-consuming than traditional on-site audits.
5. Responsive to Feedback: Implements improvements in a reasonable timeframe.
6. Customer-Centric Approach: More focused on customer needs compared to traditional notified bodies.

Scarlet Cons

1. High Learning Curve: Requires proficiency in GitHub and markdown, challenging for non-technical staff.
2. Lack of Overview: Splitting documents into multiple files makes it difficult to maintain a holistic view.
3. Unclear Process Structure: Unexpected additional checks and steps not communicated in advance.
4. Expensive Subscription Model: Potentially high long-term costs, especially for startups.
5. Rigid Software: Limited flexibility for customization or adding rationale for decisions.
6. QMS Limitations: Not a complete QMS solution, requiring additional tools and manual work.
7. Data Export Challenges: Difficulty in converting data back to traditional document formats.

Performance