Sherif, could you start by telling our readers a little about yourself and your professional journey?
My background is in biochemistry, and I’ve spent the last decade working across the medical device and diagnostics industry. Early in my career, I realised that groundbreaking innovations often fail not because of poor science, but because founders don’t understand the regulatory pathways that would get their products to market. That’s where my interest in regulation began.
Over time, I built a reputation for helping companies navigate complex requirements across FDA, EU MDR, UKCA, TGA and Health Canada. I’ve supported more than twenty global submissions, built ISO 13485-compliant quality systems, and worked with manufacturers across Europe, the Middle East, the US and Asia.
This eventually led to the creation of SMEDTEC, my consultancy, and later LENS, my regulatory intelligence platform. Today, my work spans consultancy, authorised representative services, regulatory technology, and even GPU-based infrastructure development to support AI in healthtech.
My journey essentially sits at the intersection of science, regulation, technology, and enablement helping innovators bring ideas to life safely, compliantly, and at scale.
What is your mission as a business leader?
My mission is simple: to remove friction from the global healthtech ecosystem.
I want to make it easier for companies whether in the UK, EU, Middle East, or Asia to bring safe, effective medical technologies to market. That means:
- reducing regulatory uncertainty
- providing strategic clarity
- enabling smarter, faster decision-making
- democratising access to compliance expertise
- and now, building the computational backbone that next-generation AI healthtech will rely on
I see myself as someone who builds the “invisible infrastructure” that enables innovation. Sometimes that’s regulatory strategy. Sometimes it’s quality system design. Sometimes it’s an AI platform. And today, it’s also compute power.
But the mission remains the same: support innovation that genuinely improves lives.
Tell us about SMEDTEC and your regulatory services.
SMEDTEC is a UK-based consultancy supporting medical device and diagnostics companies across global markets. We specialise in regulatory strategy, quality management, and technical documentation.
Our work spans the full lifecycle from concept through to post-market. We support FDA submissions, CE marking, UKCA, Health Canada, TGA, and most global markets.
A key part of SMEDTEC is also our UK Responsible Person (UKRP) and EU Authorised Representative (EU AR) services. These roles allow overseas manufacturers to legally sell their products in the UK and EU, and they rely on us to ensure their technical documentation, quality systems, and regulatory processes meet the required standards.
We work closely with manufacturers in diagnostics, at-home testing, point-of-care devices, dental devices, and general medical devices. Our clients range from fast-moving startups to global manufacturers.
The consultancy is intentionally lean and tech-enabled. Clients get speed, practical guidance, and direct access to expertise paired with the structure and documentation that regulators expect.
What interesting projects are you currently involved in?
I’m currently leading three major initiatives:
- SMEDTEC’s UKRP/EU AR expansion, supporting manufacturers in Asia, the Middle East, the US and Europe as they enter the UK/EU markets.
- LENS, my regulatory-intelligence platform built to help companies research regulatory information, perform predicate searches, and structure their submissions more efficiently.
- A specialised GPU compute cluster in Estonia, designed for AI healthtech development and to power LENS’ more advanced capabilities.
On the consultancy side, I’m also actively engaged in supporting diagnostics and medical device companies across the UK, EU and Australia with compliance, submissions and quality system development.
It’s a busy mix but all the projects feed into one another and strengthen the ecosystem I’m trying to build.
How do you support companies entering the UK/EU markets?
For non-UK and non-EU manufacturers, entering these markets can be daunting.
As a UK Responsible Person and EU Authorised Representative, I act as their official regulatory contact and ensure:
- their documentation meets the regulatory requirements
- the product complies with UKCA or CE standards
- vigilance and post-market activities are carried out correctly
- their market access remains active and compliant
- regulators have a reliable and qualified local representative
- Alongside this, SMEDTEC supports with:
- technical file preparation
- labelling and UDI reviews
- clinical/performance evidence
- risk documentation
- quality system alignment
- registration and listings
The goal is not just to enter the market but to do so sustainably, with compliance that will stand up to audits and regulatory scrutiny.
What is your current focus?
My time today is split across two main priorities:
1. Scaling LENS, my regulatory intelligence platform, so companies can access faster, smarter and more automated regulatory research.
2. Building the GPU cluster in Estonia, which will underpin advanced AI model development—both for LENS and for external healthtech companies.
At the consultancy level, UKRP/EU AR expansion continues to be a core focus as the UK and EU remain highly attractive markets for global manufacturers.
What is the mission of LENS?
The mission of LENS is to make regulatory understanding instantly accessible.
Regulation is complex, scattered, and often intimidating. LENS simplifies this by allowing users to:
- research FDA predicate devices
- analyse regulatory pathways
- review submissions
- extract insights from vast datasets
- structure information into manageable projects
- It transforms hours of manual searching into minutes.
The long-term vision is to build the world’s most powerful regulatory intelligence engine—one that supports companies globally and reduces time-to-market while improving compliance quality.
What makes LENS unique?
Four things make LENS stand out:
- Specialisation – It’s built specifically for medical devices and diagnostics, not general tech.
- Real-time intelligence – It interacts with FDA data dynamically and contextually.
- Project-based workflows – Users can save searches, build dossiers, and organise regulatory strategy in one place.
Integration with compute – Through the new GPU infrastructure, LENS will be able to handle larger datasets, generate deeper insights, and support more complex analysis.
Most tools show static information. LENS provides regulatory understanding.
How will the GPU cluster support AI model development and LENS?
Healthtech AI is extremely compute-intensive. Whether training diagnostic models, running simulations, or processing regulatory datasets, the workloads are heavy.
- Cloud compute is expensive and not necessarily designed for regulated AI development.
- The GPU cluster solves this by offering:
- dedicated high-performance compute
- repeatable and auditable workflows
- EU-based data handling
- lower cost at scale
- improved processing speed for LENS
It becomes both a backbone for LENS and an infrastructure resource for companies developing clinical or diagnostic AI tools.
How are you linking the UK, EU and Middle Eastern healthcare systems?
Through SMEDTEC and LENS, I regularly support companies from the Middle East looking to launch in the UK or EU. Similarly, UK and EU companies are increasingly interested in Gulf markets.
The GPU infrastructure in Estonia creates a third link—an EU-based compute environment accessible to companies globally.
So I see my work forming a triangle:
- UK → regulatory strategy, compliance, and UKRP
- EU (Estonia) → compute infrastructure and EU authorised representation
- Middle East → fast-growing demand for diagnostics, AI and digital health
This creates a pathway for companies to move between regions with clarity, infrastructure and support.
What is the main challenge facing AI in healthtech?
The biggest challenge is that AI development has outpaced the infrastructure and regulatory frameworks needed to support it.
Companies struggle with:
- the cost of compute
- the need for traceability and auditability
- uncertainty around regulatory expectations
- data governance
- performance validation
My approach is to solve this from both sides:
- Regulatory clarity through SMEDTEC & LENS
- Computational capability through the Estonian GPU cluster
In other words, you cannot scale medical AI without the right regulation, and you cannot meet regulatory expectations without the right compute.
I’m building both.
How do you see the future of healthcare evolving with digital transformation?
I believe the biggest shifts will be:
- Diagnostics moving closer to the patient
- AI powering decision-making in both clinical and home settings
- A surge in personalised and algorithm-driven tools
- Regulatory frameworks becoming more dynamic and data-driven
- Global collaboration strengthening across regions
The winners will be those who combine clinical insight, regulatory robustness, and technological capability.
What is your future vision for yourself and your ventures?
My long-term vision is to create a globally recognised ecosystem for medical innovation—where regulatory expertise, AI capability, and compute infrastructure intersect.
I want SMEDTEC to remain the consultancy of choice for medical device and diagnostic innovators.
I want LENS to become the most advanced regulatory intelligence platform globally.
And I want the GPU infrastructure to grow into a scalable compute network supporting AI healthtech companies around the world.
Most importantly, I want everything I build to enable safer, faster and more accessible healthcare innovation.
Where can readers find out more?
Readers can learn more at: www.smedtec.co.uk
I’m also active on LinkedIn, where I share insights on regulation, digital health and AI innovation, follow me at:
