EU AI Act deployment

Since August 2nd the EU AI Act is in force. But is it?
In practice: not much today, but the clock has started. If your device includes an AI component or uses AI to support decisions it’s time to take a closer look.

For high-risk systems, including many AI-based medical devices, there’s a 36-month transition to comply, i.e. phased implementation. However, some provisions apply earlier (e.g. banned uses of AI, codes of conduct).

Here’s what I see across medtech:
1. Confusion around scope and classification, e.g. AI as a tool for CSV or as part of the intended use?
2. Assumptions that MDR = AI Act compliance, thus reactive attitude to QMS updates upon NB feedback rather than in a proactive manner
3. Teams don't know how to resource it.

Good thing is that I also see a booming AI-related offering from QARA consultants and training providers which can help if you’re stuck on any of the above points. Cool examples (among many others):

• AI-first QARA frameworks and training e.g. Johner Institut GmbH https://lnkd.in/dBSuFfie,
• AI agents for compliance-checking and even FDA review outcome prediction such as Lexim AI or Acorn Compliance,
• GenAI embedded in eQMS tools such as Formwork from OpenRegulatory or Matrix One

What would help your team implementing the AI Act? Curious to hear your challenges and to help you with the right support.

Steep rise in FDA fees for 2025-2026

Alert 🫰 Steep rise in FDA fees from this October:

+19% Annual establishment registration fee from $9,280 to $11,423 (this is the one you pay every year for keeping the right to place a device on the market)

+7% Application fees, e.g. 510k submission from $24,335 to $26,067 (this is the one-off fee for review of a product submission file)

Bad news for early stage medtech businesses and SMEs, in particular since no "small business discount" nor waivers apply on the establishment fee at first registration.

Note, small businesses may qualify for waiver on the establishment fee (2nd year on) and a reduced application fee (e.g. 510k for $6,517 instead of $26,067, new fees) under the SBD programme. Conditions are based on gross sales and justification of "financial hardship", rather than on company size. Worth looking into.

See latest MDUFA fees on the FDA website at this link.

Quality whistleblower - hero vs martyr

How do you make yourself heard when you MUST raise the redflag over design quality, production compliance, clinical safety?

It's an incredibly difficult position to be in, whether you're acting from inside a company or as an external reviewer, stakes are high and office politics (if not even higher politics), budget concerns, along with own self-limiting beliefs, come into play giving you many reasons why you shouldn't follow your gut. Maybe I'm wrong, maybe it's all well. Or maybe it isn't?

I've been in this position before a couple of times as PRRC. It's dire, sleepless nights, conflict escalation. Escalate it to whom? If the technicians or QA's voice is not heard, and your voice as PRRC is not heard, then you hope external parties such as lawyers, consultants, CROs, reviewers will be more effective gate keepers, but then they aren't. They may overlook things or also have their own interests at play. Then who is left to protect the patient? Who is going to stand up and stop the chain of events before it's too late?

The story of Frances Oldham Kelsey, FDA medical reviewer in the 60s who refused to approve Thalidomide is a great example, and similarities can be seen in other preventable disasters such as Titan's OceanGate, Boeing's 737max MCAS software, or Chernobyl to name the most famous. All had a long chain of brave flag raisers in a culture that shut them down..

Culture is key and of utmost importance in medtech. Accountability, feedback and psychological safety create space for risks to be raised and taken seriously at any stage of a project. So called "Type 1 decisions" in business, i.e. non-reversable (launch or not launch?) need true raw information, not just the glossed version that the manager is willing to lend an ear to.

A culture that integrates Quality as their biggest asset and strategic partner will value anyone who raises issues, mistakes, inefficiencies, with a view of preventing not only harm but also resources and reputational risks.

I'm so deeply passionate about driving such cultural shifts and help teams innovate in the most progressive, forward-looking and responsible ways.

What is “quality” really?

I am often asked: what is “quality”?

I find it funny how often this question comes up in my field and how much debate it sparks over and over again. I cannot think of many other professions that would routinely take you to re-discuss and reassess their own purpose and definition at such philosophical depths.

Each one of us has a different take on what “quality” or “good” means depending on what most matters to us or what is the object we are talking about. And that's what makes it so personal and ambiguous. Good quality furniture is sturdy and durable. A good quality smartphone should be fast and reliable. Yet good quality in the service industry may be tied to delivery and customer support.

What do all these have in common? Expectations and accountability.

As the end user you want to know that what you are getting - whatever that is - really meets your needs. You want to know that what you read about it is trustworthy and not only the result of creative marketing. You also want to know that if something goes wrong with it, the provider will have your back and will take responsibility for it.

So although “quality” may seem at first as a highly subjective attribute, it eventually boils down to something tangible and product-agnostic. Know your customers' needs, know what you're giving to them, act upon problems. This is effectively what quality standards are all about. A set of requirements for any industry (or in certain cases sector specific) that unifies what quality means for all and defines how to prove it unambiguously.

In the case of medical products quality is clearly paramount. The expectation for genuine health outcomes and for service accountability are closely tied to our own wellbeing, our safety, our privacy and security - or that of our loved ones. As much as we may try and inform ourselves to discern good quality products from bad quality products, there's a limit to what one individual's understanding can achieve. Products and companies alike can be incredibly diverse and complex, and to effectively scrutinise different therapeutic options one would need to be simultaneously an expert in medicine, science, technology, law, security, privacy, all in one. As consumers and as patients, this is an unfair burden. This is why the health industry is regulated and requirements are standardised. This is why there is a system and diverse teams of experts doing it on our behalf and in our interest, from pre-market approval to post-market surveillance. National health authorities safeguard users to ensure transparency and accountability.

As any complex system and human endeavour, the quality framework is not perfect, of course. Unfortunately, operating quality in a compliant way doesn't translate 100% in assurance of good practice or intentions, as some companies choose to treat it as a mere checkbox exercise. But even that, one could argue, is better than nothing. On the opposite end of the spectrum, companies with good practices can really struggle to align to the ever more complex standardised system. The complexity and resource investment can sometimes be overwhelming and off-putting for young startups, and this can hinder innovation and delivering value to users who need it.

To me, personally, quality means "good practice, consistently". Good as in responsible, safe, ethical, just, effective, efficient. Consistent as in habitual, auditable, reliable. My previous experience in science, process optimisation, sustainability and in Corporate Social Responsibility (CSR) have given me a broad perspective that for a long time I worried being too dispersive. Yet somehow it seems to have converged into this mission and passion for driving quality. The most satisfying feeling is to see a young startup through, from visualising its early quality ambition to reaching a mature governance structure in a value-aligned quality system. By supporting organisations understand what quality truly means to them and making it workable for them, we advance the value proposition of the whole sector. To me, it means making things better in this world, a step at a time.