Uncovering the Hidden World of Certifications

Pick up any manufactured object, and you should find a stamp of approval. In Europe, parents look for the CE mark to know toys are safe. In the UK, the UKCA mark means that toughened glass will crumble safely when broken. One of the most stringently regulated markets is medical devices. Everything from ultrasound machines to stethoscopes needs to show devices are certified as safe and effective. These symbols point to the hidden world of the Testing, Inspection and Certification (TIC) industry – the near-invisible layer of certifications that shape our world.

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From the Industrial Revolution to AI Age

To understand the certification industry, it’s worth indulging in a short history lesson. In every era of major technological change, governments created rules to standardise the new products that emerged. They typically delegate the responsibility for checking these products to certification bodies. For instance, when global trade exploded in the 18th century, we needed trusted cargo checks. With the steam engine, factories needed safe boilers. And electrification needed checks for fire-safe appliances. Each era has created certification giants that now command billions in revenue:

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The advent of AI demands its own certification body that is fit for purpose. One that both understands AI products and operates as an AI-native service, at the cadence of the AI-driven product development lifecycles. Scarlet is that certification body for the AI age. 

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Enter Scarlet - the AI-Native Certifier

Scarlet was founded by two machine learning (ML) engineers, James Dewar and Jamie Cox, who had lived through the challenges of trying to get AI/ML healthtech products certified. They faced months, if not years, of delays as they waited for their tech to be reviewed. They felt there had to be a better way, and Scarlet was born.

Scarlet now holds certification powers equal to the incumbents, authorised to certify in the most rigorous geographies – the EU, UK, and US – and in the most exacting field: medical devices. 

Scarlet is now riding on a triple tailwind of the AI age: AI is unlocking more products that need certification; AI is speeding up regulatory submissions; and Scarlet’s AI is speeding up product approvals.  

That’s why we’re delighted to be investing in Scarlet’s $50M Series B alongside Headline Growth and existing investors Atomico, Creandum and Kindred. 

A few core theses underpin our conviction in Scarlet:

1. Scarlet is an AI native service that delights customers with unparalleled efficiency in the assessment process 

Through their team of expert assessors working with AI agents, Scarlet operates with a level of efficiency that is unmatched in their industry. Scarlet delivers fast, high-quality customer outcomes that drastically improve the assessment experience for cutting-edge healthcare manufacturers.

The calibre of this service earns the company rave reviews from clients, from AI native startups to Fortune 500 healthcare giants. Customers praise Scarlet’s strong partnership in rapid product development and Scarlet’s rigor in its reviews. 

2. Scarlet moves certifications from human scale to AI scale – meeting the pace of agentic product development

By using AI agents to support assessors, Scarlet is transforming an industry bound by human pace and accelerating it to AI’s pace. To quote a Scarlet customer: “Scarlet has built a Notified Body for the AI world.” 

With this efficiency, Scarlet is purpose-built for the iterative nature of AI and software technology. Product updates and changes can be handled quickly and smoothly, rather than through a lengthy process that causes further delays.  

Speed is especially important to the wave of innovation we are seeing today as the AI platform shift intersects with healthcare. Product development lifecycles are compressing, transforming into what we call “agentic product development”. We see two key dynamics unfolding :

• Healthcare products are increasingly driven by the AI innovation inside them, which iterates constantly. Healthcare companies now need to update their products fast and get them to market fast, at pace with the latest AI developments. With Scarlet, managing and iterating AI device suites is wrapped into the ongoing service. Only Scarlet’s AI-driven model can match the ambition of today’s healthcare innovation. 

• AI tools are accelerating the product development process itself – as well as regulatory submissions for market access. AI coding agents are ramping up the cadence and volume of the new software-defined healthcare products launched. At the same time, new AI tools to help healthcare companies meet regulatory hurdles are accelerating submissions to certifying bodies. More manufacturers are clamouring for market access from the certifiers. As AI agents develop the product and ask for regulatory approvals, an agentically driven certification body is necessary to match this demand.

3. Scarlet’s certification expertise is in AI – precisely what is driving healthcare innovation today

Novelty in healthcare today lies in AI. Think robotic surgery, AI radiology and AI diagnostics. The medical hardware here is well understood and mature: robotic arms, microphones, MRIs, and scanners themselves are not new. But the intelligence driving them is.

Among the 52 bodies designated under the EU Medical Device Regulation, Scarlet is the only one that specialises in software and AI. Scarlet is the premier partner for healthcare companies bringing AI-driven products to market because it is the certification body with the deepest understanding of the cutting-edge of medical devices.

Importantly, Scarlet’s AI-native service model is a market enabler, triggering a virtuous cycle of investment and innovation. Fast, AI-literate certification brings more products to market, which attracts more R&D investment and, in turn, creates more devices needing certification. This feedback loop expands Scarlet’s potential market. 

4. Scarlet has accumulated regulatory power with a deep moat 

Early on in Scarlet’s journey, the founders recognised that having regulatory power equal to incumbents was critical to making their AI-native service model work. They spent the first years becoming a Notified Body under the EU Medical Device Regulation (“MDR”) and an Approved Body under the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”). This status now acts as a springboard into additional markets and certification powers. 

Scarlet has developed a unique comparative advantage in accumulating and maintaining certification powers – expertise, knowhow and process power. They have shown they can win this trust from regulators in multiple geographies and domains. Now Scarlet holds medical device designations from the EU, the UK’s MHRA, and the US FDA, where it is recognised as a Third Party Review Organization, and it offers certification against MDSAP, ISO 13485, ISO 27001, and ISO 42001. 

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What’s Next? Scaling a Certification Body Fit for AI

With this Series B, Scarlet plans to significantly expand its offering to meet even broader customer certification needs, grow its team of experts and their AI agents, and increase its footprint in the US and APAC. 

Like the changes of the past – the advent of global trade, the Industrial Revolution, and electrification – AI presents a tectonic shift in technology. And as AI intersects with healthcare, creating a new wave of products to improve human health, this demands a new kind of certification body. Scarlet is that certification giant fit for the AI age, pulling the healthcare technologies of the future into the present. 

We are proud to back James and Jamie at their $50M Series B as they build out Scarlet. In the decades to come, look out for the Scarlet compass marking their certification on the next wave of AI products.

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Why Notion Capital? A note from Scarlet co-founder Jamie Cox

“In Notion we have found partners who share our vision for what global AI certification can become and the impact it will have for healthcare around the world. They see the critical importance of fast, specialised assessment processes fit for the most ambitious technology companies. We’re excited to have their support as we enter this next chapter of Scarlet’s growth.”