Quantum: The Regulatory Frontier That Will Catch Us Off Guard

Yesterday, I met Sabrina Maniscalco, CEO of Algorithmiq, at the Italian Tech Forum in Zurich. They develop quantum algorithms for life sciences, including applications in cancer therapy. Despite having taken two courses in quantum physics at university and working extensively with AI/ML medical devices, I found myself needing to educate myself from scratch on what quantum computing means for our field.

What I discovered was both inspiring and unsettling: we're standing at the edge of a paradigm shift in medical technology, and regulatory science isn't even looking in that direction yet.

What Is Quantum Computing and Why Does It Matter?

Classical computers operate using bits, each either 0 or 1. Quantum computers use qubits that can exist in multiple states simultaneously through superposition. Qubits can also be entangled, meaning their states are interconnected regardless of distance. This allows quantum computers to process vast possibilities in parallel in ways classical computers simply cannot replicate.

For medtech, this isn't academic curiosity—it's transformative capability. Classical computers struggle to simulate even simple molecules beyond a certain size. A molecule with just 30 atoms has more quantum states than a classical computer can practically track.

Quantum computers can model:

• Drug-molecule interactions at atomic precision

• Protein folding and three-dimensional structures

• Tumor microenvironments at cellular and molecular levels

• Personalized treatment responses based on genetic profiles

The AI-Quantum Hybrid Approach

During our conversation, Sabrina explained: "AI is only as good as the data it's trained on. With quantum computing, we can generate vast amounts of physically accurate data and then train AI on it. Imagine the possibilities from simulating the behavior of ALL atoms in our body."

This is Algorithmiq's innovation: combining quantum computing with AI to address one of AI's fundamental limitations—the need for massive training data.

For many biological phenomena, we simply don't have enough experimental data. It's too expensive, too dangerous, or physically impossible to measure. Quantum computers can generate synthetic training datasets that are physically accurate—based on quantum mechanics—but impossible to obtain experimentally.

Sabrina mentioned that quantum computing capabilities are now available on the cloud, with enterprise access in the million-dollar range annually. For specific computational problems, quantum computers can be more efficient than traditional supercomputers.

Algorithmiq has already announced partnerships with Microsoft (December 2024) and Quantum Circuits (February 2025) to accelerate drug discovery.

A Concrete Example: Photodynamic Cancer Therapy

One particularly compelling application demonstrates quantum computing's real-world impact: photodynamic therapy (PDT) for cancer.

PDT uses special molecules called photosensitizers that are activated by light to produce therapeutic effects. The benefits are significant:

• No long-term side effects

• Less invasive than surgery

• Outpatient procedure

• Precisely targeted

• Can be repeated at the same site (unlike radiation)

• 5-10 times less costly than other cancer treatments

The challenge lies in designing these photosensitizer molecules. It requires understanding tiny energy gaps between electronic states—differences that dictate how molecules behave when exposed to light. Classical quantum chemistry algorithms struggle to calculate these energy gaps with the necessary accuracy.

Using IQM's Emerald quantum processing unit and Algorithmiq's advanced error mitigation techniques, the team achieved a 100x improvement in precision compared to results from other quantum hardware providers. This work, part of the Wellcome Leap Q4Bio Challenge, is establishing an end-to-end quantum-centric drug discovery pipeline for light-activated anti-cancer drugs.

They're focusing on the BODIPY class of compounds—next-generation photosensitizers. With quantum computing, simulating their energy landscape becomes possible with unprecedented accuracy, paving the way for better-targeted therapies developed faster and more cost-effectively.

This is happening now.

Closing Health Data Gaps

We also discussed possibilities that particularly resonate with my work in femtech: using quantum computing to simulate complex biological systems like women's physiology to close health data gaps that are difficult or impossible to obtain experimentally.

Women's health research has historically been underfunded. Menstrual cycles, pregnancy, menopause—these introduce biological complexity that makes clinical trials more expensive and results harder to interpret. What if quantum simulation could help bridge these gaps by modeling hormonal interactions and reproductive system responses with atomic-level precision?

The Regulatory Challenges Ahead

Here's the uncomfortable truth: none of medtech's regulations or guidances currently contemplate quantum-AI hybrid diagnostics or therapeutics.

Challenge 1: The Validation Paradox

How do you validate quantum-generated data when you can't reproduce it classically?

The FDA's recent draft guidance on AI/ML-enabled device software (January 2025) requires manufacturers to disclose synthetic data provenance, describe algorithms used to generate it, and demonstrate it preserves clinical correlations. These are sensible requirements for classically-generated synthetic data.

But they break down when the "algorithm" is a quantum computer simulating physics that classical systems fundamentally cannot reproduce. How do you verify quantum-generated molecular data "preserves clinical correlations" when there's no classical ground truth? The entire point of quantum computing is simulating phenomena classical computers cannot.

Challenge 2: Black Box Squared

AI is already a "black box"—how do we maintain our ability to explain and reproduce the operating principles when we layer quantum computing on top?

Explainability is already a regulatory challenge. The EU MDR Article 61 and FDA guidance emphasize transparency in clinical decision-making. But AI models, particularly deep learning, are notoriously opaque.

Add quantum computing—inherently probabilistic, extraordinarily sensitive to environmental interference—and we're layering one form of opacity on another. Yet regulatory frameworks require that medical devices be explainable, reproducible, and transparent.

The FDA's three-pillar framework for Software as a Medical Device asks:

1. Is there a valid clinical association between device output and clinical condition?

2. Does the software correctly process input data?

3. Does use of the output achieve the intended purpose?

For quantum-AI systems, how do you analytically validate "correctness" when there's no classical benchmark?

Challenge 3: Cybersecurity and Q-Day

Quantum computers will eventually break current encryption methods—a threat called "Q-Day." This poses serious risks:

• Adversaries can collect encrypted medical data today and decrypt it later

• Medical devices relying on current cryptographic protocols will be compromised

NIST announced its fifth quantum-safe algorithm in March 2025, but adoption in medical devices has been slow. Medical device manufacturers should implement quantum-resistant encryption immediately.

What Regulatory Frameworks Currently Exist?

The closest we have are two recent FDA guidances:

FDA Guidance on Real-World Evidence (December 2025) emphasizes that data must be relevant and reliable, with a fit-for-purpose approach. This potentially opens a pathway: quantum-generated synthetic data could be acceptable if manufacturers demonstrate it's the most appropriate method for answering specific clinical questions.

FDA Guidance on AI/ML-Enabled Device Software (Draft, January 2025) addresses data management, synthetic data requirements, performance validation—but all assuming classical computational paradigms.

Neither contemplates quantum-generated training data, validation when classical reproduction is impossible, or uncertainty quantification for quantum probabilistic outputs.

The EU AI Act, MDR/IVDR, and ISO standards similarly don't address quantum computing.

Why This Matters Now

Waiting until quantum devices reach the clinic or reach their "ChatGPT moment" means we'll be reactive instead of proactive, again.

We've seen this pattern with AI. By the time ChatGPT brought AI to mainstream awareness, the technology had been developing for decades. Regulators scrambled to catch up.

But AI builds on classical computing principles we already understood. Quantum computing is fundamentally different. The learning curve is steeper, the validation challenges more complex.

If we wait until a quantum-enhanced diagnostic applies for FDA clearance before starting these conversations, we'll be years behind.

So, what needs to happen?

Regulatory agencies may:

• Introduce quantum-aware terminology in guidance documents

• Establish working groups bringing together quantum scientists, device developers, and regulatory professionals

• Develop validation frameworks specifically for quantum-generated synthetic data

• Issue guidance on quantum-resistant cybersecurity for medical devices

Industry may:

• Engage early with regulators through pre-submission meetings

• Document quantum approaches in detail

• Build quantum literacy within regulatory and quality teams

• Implement post-quantum cryptography now

Thank you to Sabrina Maniscalco for the thought-provoking conversation, and to Camera di Commercio Italiana a Zurigo for creating the space where these insights happen.

References

• Algorithmiq's Photodynamic Therapy Demonstration

• IQM Quantum Breakthrough in Cancer Therapy

• FDA Software as a Medical Device (SaMD): Clinical Evaluation

• FDA guidance: “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”

• FDA guidance: “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”

• FDA guidance: "Software as a Medical Device (SAMD): Clinical Evaluation"

  Methodology Note: This article is based on my original LinkedIn post, reflecting my professional experiences and personal perspectives. Claude AI assisted in elaborating the post into a broader article by integrating personal notes, literature research, fact-checking and deeper insights on the topic. All analysis and regulatory perspectives are my own, and all content has been reviewed by me for accuracy.

Beyond the EU-US paradigm

The recent speech delivered by Canada's Prime Minister at the World Economic Forum prompted me to reconsider my approach to regulatory strategy. Without delving into politics, the address highlighted the extent to which the western world has become US-centric and reliant on American frameworks—a reality that extends fully to the medical technology sector.

This led me to reflect on my own professional practice:

• Most of my analysis focuses on comparative regulatory matters between the EU and US.

• Most of my medtech clients prioritize EU and US market entry first, and that is what I help them achieve.

• Most of my knowledge accumulated over 14 years in healthtech has been built on the default EU-US paradigm.

However, I am far from blind to the strong signals of change emerging on a global level.

Major medtech corporations are beginning to pursue UAE market entry first, given that average regulatory approval timelines are 30%-50% shorter than in the US and EU. Many emerging economies maintain low regulatory barriers for standalone Software as a Medical Device (SaMD) in digital health—large markets such as Mexico and Nigeria only introduced such requirements in 2023 and 2025, respectively. Meanwhile, Canada, Australia, and the UK are taking bold steps to boost health innovation, attract technology companies, and facilitate regulatory compliance.

As former Bank of England Governor Mark Carney stated in his remarks:

"In a world of great power rivalry, the countries in between have a choice: to compete with each other for favour or to combine to create a third path with impact."

"The question is not whether to adapt—we must. The question is whether we adapt by simply building higher walls or whether we can do something more ambitious. The former is easy and ruinous; the latter is difficult and necessary."

This brings me to an important question for the medtech regulatory community.

Beyond the US-EU 'old order', which regulatory focus would you find most valuable for future analysis and guidance?

1. Anglosphere: Canada, South Africa, Australia, New Zealand

2. "BRIC" + Japan: Brazil, Russia, India, China, and Japan

3. Middle East: UAE, Saudi Arabia, Israel

4. Emerging Markets: Africa, ASEAN, Latin America
   
   I invite you to share your perspective in the poll here

Plasters Vs Period Products

If plasters are Class I medical devices in the EU, why shouldn't tampons be held to the same quality and biocompatibility standards?

It's a question that seems obvious once you think about it. A plaster sits on your skin for a few hours. A tampon is inserted into one of the most absorbent mucosal tissues in the body, often for 4-8 hours at a time, repeatedly, for decades of a person's life.

Yet in the EU, menstrual products—including cups, pads, and tampons—are classified as hygiene products under the General Product Safety Regulation (GPSR), not medical devices. Unless, that is, manufacturers choose to voluntarily market them as medical devices.

Under the Medical Device Regulation (MDR), manufacturers can voluntarily classify their menstrual products as medical devices by applying Rule 4:

• Class I, if non-invasive medical devices act as a mechanical barrier for absorption and come into contact with a mucous membrane

• Class IIa, if controlling the micro-environment of the mucous membrane or diagnostic

This voluntary pathway exists—but very few manufacturers take it. And here's why that matters.

What's the Difference?

The gap between a hygiene product and a Class I medical device isn't just bureaucratic classification. It's a fundamental difference in accountability and safety standards:

Product Design & Testing

• Hygiene product: Basic safety assessments under GPSR

• Class I medical device: Thorough documentation and biocompatibility testing for cytotoxicity, irritation, sensitization, and leachables per ISO 10993

Legal Paper Trail

• Hygiene product: Non-standardised quality systems

• Class I medical device: Mandatory ISO 13485 Quality Management System with full traceability from raw materials to finished product

Production Environment

• Hygiene product: "Clean" room (undefined standards)

• Class I medical device: Certified cleanroom with documented environmental controls

Surveillance

• Hygiene product: Reactive response to complaints

• Class I medical device: Proactive post-market surveillance, vigilance reporting, and periodic safety updates

These aren't trivial differences. They're the scaffolding that ensures product safety when something is inserted into your body thousands of times over your lifetime.

US Takes a Different Approach

Here's where it gets interesting: in the United States, menstrual products are regulated as medical devices by the FDA:

• Pads: Class I medical devices

• Tampons and cups: Class II medical devices (requiring 510(k) premarket notification)

This means, in principle, a higher baseline for quality and safety of menstrual products in the US compared to the EU.

But—and this is important—there are two contrasting factors that complicate this picture:

Factor 1: The Predicate Problem

FDA clearance for Class II devices relies on proving "substantial equivalence" to a pre-existing product (the predicate). For menstrual products, many of these predicates are decades old, with correspondingly low benchmarks.

The 510(k) pathway asks: "Is your product substantially equivalent to this 1980s tampon?" Not: "Does your product meet 2025 safety standards?"

This creates a regulatory floor that hasn't risen substantially in 40+ years. Manufacturers must demonstrate biocompatibility and safety testing, but the comparison point is historical, not state-of-the-art.

Factor 2: EU's Horizontal Chemical Legislation

The EU has stronger horizontal legislation than the US, with general bans on:

• Carcinogens, mutagens, and reprotoxic (CMR) substances

• Endocrine disruptors

• Certain phthalates and parabens

• Specific pesticide residues

These bans apply to all consumer products, including hygiene products, through REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the General Product Safety Regulation.

The new GPSR (which fully applied from December 2024) strengthens these protections:

• Mandatory risk assessments before market placement

• Technical documentation of hazards and mitigation

• Designated EU responsible person

• Enhanced traceability (batch coding for rapid recalls)

• Proactive approach to safety, not just reactive

Additionally, the EU Ecolabel criteria (updated September 2023) ban many hazardous substances from certified products:

• Antibacterial agents

• Formaldehyde

• Parabens

• Endocrine disruptors

• Phthalates

• Allergenic fragrances

So while EU menstrual products aren't medical devices, they benefit from chemical safety requirements that make even hygiene products safer than some US medical devices might be, depending on their predicate.

The voluntary approach: Daye’s case

This is where companies like Daye become important. Founded and led by Valentina Milanova, Daye chose to produce tampons to medical device standards—even though they're not legally required to in the EU.

What does this mean practically?

Cleanroom production: Daye manufactures tampons in an ISO 14644-1 Class 7 cleanroom, the same standard required for medical device production. This isn't just marketing—it's certified, monitored environmental control.

ISO 13485 QMS: Full quality management system compliance, ensuring operations from production to testing to post-market surveillance match medical device requirements. When Daye identifies an issue with a tampon, they can trace every raw material that went into it and check other batches.

Gamma ray sterilization: Medical-grade sterilization to eliminate microbial contamination, reducing TSS (Toxic Shock Syndrome) risk.

Biocompatibility testing: Testing for cytotoxicity, irritation, sensitization—the full ISO 10993 battery that medical devices require.

Batch testing: Testing for pesticides, dioxins, heavy metals, CBD content (for their CBD tampons), THC content.

Full ingredient transparency: Voluntarily disclosing all ingredients and manufacturing processes, even though GPSR doesn't require it.

The result? Products manufactured to the same standard as stents and hip replacements—for something you insert vaginally multiple times per month for 30+ years of your life.

The Daye Warning Letter: A Cautionary Tale

In December 2024, the FDA issued a warning letter to Daye regarding their CBD-infused tampons. The letter highlighted a critical regulatory challenge: Daye's tampons were cleared under K223883 with indications "to absorb menstrual discharge," but their labeling and promotion suggested the device was "intended for relief of period related pain"—a major change in intended use requiring separate clearance.

This illustrates the complexity manufacturers face when trying to innovate in this space. Daye was attempting to address a real medical need (90% of menstruating people experience dysmenorrhea), but doing so triggered different regulatory requirements.

This tension between innovation and regulation is exactly why clear, appropriate frameworks matter.

Why This Matters for Women's Health

The average person who menstruates will use 11,000-17,000 tampons or pads in their lifetime. That's decades of exposure to whatever materials, chemicals, and contaminants are in those products.

Recent research has raised concerns:

• A 2024 UC Berkeley study found heavy metals (lead, arsenic, cadmium) in multiple tampon brands

• 2023 studies detected PFAS ("forever chemicals") in menstrual products, even those marketed as PFAS-free

• Vaginal and vulvar tissues absorb chemicals more rapidly than skin

Yet in the EU, manufacturers aren't required to:

• Disclose ingredients on packaging

• Test for specific contaminants beyond what GPSR mandates

• Follow medical device biocompatibility protocols

• Maintain cleanroom production environments

• Conduct proactive post-market surveillance

The US requires slightly more (TSS warnings, tampon absorbency labeling) but doesn't mandate ingredient disclosure either, and the FDA only recommends (not requires) testing for pesticides, herbicides, dioxin, and specific pollutants.

The Bottom Line

Irrespective of regulatory stance, what matters is that menstrual products are produced safely and responsibly.

Kudos to Daye, Valentina Milanova, and Lisa Rodwell (ex-CEO) for pushing a whole sector towards higher standards. When a company voluntarily adopts medical device manufacturing standards for products not legally required to meet them, it demonstrates what's possible.

But we shouldn't rely on voluntary adoption. When a product is inserted into highly absorbent mucosal membranes for hours at a time, thousands of times over decades—shouldn't that merit the same regulatory rigor as a plaster on your skin?

The EU's chemical safety legislation provides strong horizontal protection. The US's medical device classification provides structural accountability. Both could learn from each other.

And both could learn from companies like Daye: when you manufacture for the body you actually have—not the regulatory minimum—everyone who menstruates benefits.

References

• EU General Product Safety Regulation (GPSR)

• Why Menstrual Products Aren't Medical Devices in the EU

• FDA Guidance: Menstrual Products

• Daye Manufacturing Process

• FDA Warning Letter to Daye (December 2024)

• Linkedin Post: Daye’s cleanroom facility

Methodology Note: This article is based on my original LinkedIn post, reflecting my professional experience in femtech regulation and research into EU and US menstrual product regulatory frameworks. Claude AI assisted in elaborating the post into an article by integrating personal notes, literature research, fact-checking and further insights on the topic. All analysis and regulatory perspectives are my own, and all content has been reviewed by me for accuracy.

Crans-Montana, a compliance perspective

Regulation is often seen as pain in the neck… until it isn't. A national tragedy takes place in Switzerland on NYE, and we ask ourselves why didn’t this underground bar have compliant emergency exits? Why wasn’t it inspected in more than 5 years? How could a combustible soundproofing material be permitted and line the whole ceiling? How could staff pull off such a deadly stunt (regularly!) with zero awareness about fire risk? Why the heck were the victims-to-be filming instead of fleeing??

And in particular, how could ALL these hazards manifest simultaneously??

I am horrified by the incident in Crans-Montana (news article). It should never have been. It lights up the painful memory of the Grenfell tower fire in 2017, which had shocked me deeply as I was living in London back then.

We all assume and expect to be protected by regulation. We all assume and expect compliant and responsible behaviour of others. The reality is that if things go south, we are on our own to face the consequences. We all have a responsibility to do our bit, whether it’s fire safety or health.

Being alert to risks, and raising the awareness of others too. Informing yourself and doing your best at least, not ignoring. Holding others accountable by asking questions or reporting unsafe practices. Raising your voice to policy-makers if something isn't enough.

I hope my work does a bit on all these things, within the realm of healthtech, of course, not fire regulation.

As a result, Switzerland now banned the use of pyrotechnics in indoor spaces and is investigating not only the bar owners but the municipality, that did not inspect the bar ONCE in 5 years. The sale of any flammable soundproofing materials is also under scrutiny.

Could this bring into 2026 a bigger wave of respect for regulation and compliance? Am I hopelessly wishful?

Today in Switzerland is a national day of mourning for the 40 victims, mostly teenagers. It breaks my heart to think of what’s left of the 116 injured.

I pray for them and for something like this to not be allowed to happen again - by regulators, by business owners, by fellow citizens, by luck (that's a factor too..🍀), by us all doing our little responsible part in society.

(Image rights: https://www.bbc.com/news/articles/c9dvyyjyj18o)

If “wellness” cosmetics are regulated, why isn't “wellness" tech?

While diving into a new cosmetics project, I saw this angle, then tilted my head and... "I couldn’t help but wonder": do people realise cosmetics carry real compliance duties despite no medical claims?

Cosmetics must show, at mininum:
▶️ Manufacturing quality: GMP (ISO 22716) + national rules (e.g., EU 1223/2009, FDA 21 CFR 700)
▶️ Safety & testing: microbial load, stability/shelf life, toxicological assessment
▶️ Accountability & traceability: labelling, INCIs disclosure, product registration (e.g., EU CPNP), adverse event reporting
▶️ Governance: a designated Responsible Person, inspection-ready procedures & technical documentation

In principle, not at all far from medical devices, just rightly lighter in scope and depth.

I’m seeing both directions lately: wellness products drifting into medical territory and claim downgrades to step out of it (especially post-MDR transition end). As medical regulations tighten, new categories - and opportunities - emerge at the edges. The fluid interface is such an exciting place to be ❤️‍🔥.

My view:
Health/body-affecting products should meet proportionate standardisation and accountability. I’d favour a distinct “health and wellness-tech” category with its own rules (as cosmetics have, as the FDA is exploring) over forcing medical device frameworks around them.

Do you agree? Do you also see a rise in review of claim strategy by health product manufacturers (whether upwards or downwards)?

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.