Regulatory clarity for medical device innovators
Strategic regulatory guidance for EU MDR, UKCA and FDA pathways
Regvo supports medical device startups and growing companies through the regulatory journey — from early classification and strategy to certification and post-market compliance.
Our goal is to help you move forward safely, efficiently, and with confidence.
Regvo is a specialist regulatory consultancy built on hands-on medical device regulatory experience across EU, UK, and US frameworks. We work with startups, SMEs, and growing MedTech companies that need regulatory clarity, practical execution, and a trusted partner who will support them through every stage of the journey.
The Problem
Regulatory requirements are often unclear, fragmented, and overwhelming — especially for innovative teams without in-house regulatory expertise.
You may be asking:
- Is our product a medical device?
- Which regulatory pathway applies to us?
- What documentation is actually required?
- How do we stay compliant without slowing innovation?
Wrong decisions early on can cost time, money, and credibility.
That's where Regvo comes in.
Supporting you through the entire certification journey
Medical device regulation is not a single step — it is a structured journey. Regvo supports clients across the full regulatory lifecycle, so you always know what comes next and are never left navigating it alone.
Product Qualification
Determining whether your product meets the legal definition of a medical device is the essential first step. We help you assess your product's intended purpose and establish its regulatory status with clarity and confidence.
Classification
Correct classification drives every decision that follows — from documentation requirements to conformity assessment routes. We provide clear, defensible classification decisions aligned with EU MDR, UKCA, and FDA frameworks.
Regulatory Strategy
A well-structured regulatory strategy saves time and avoids costly rework. We define the optimal pathway for your product, market, and development stage — giving your team a clear plan to follow from the outset.
Technical Documentation
Technical files and design dossiers must be accurate, complete, and compliant. We support the preparation and review of your documentation to meet regulatory requirements and withstand scrutiny.
Certification Process Support
From Notified Body selection through to conformity assessment and CE or UKCA marking, we guide you through the certification process step by step — helping you respond to queries and progress efficiently.
Post-Market Compliance
Regulatory obligations do not end at certification. We support ongoing post-market surveillance, vigilance reporting, and lifecycle compliance so your product remains market-ready as requirements evolve.
Online Programme
Regulatory Fundamentals Program
From zero regulatory knowledge to understanding your pathway — in 4 weeks.
View programme & pricingWho We Work With
Regvo works with companies that are serious about regulation but do not yet have the in-house expertise to navigate it alone.
Medical Device Startups
Early-stage teams building innovative devices who need regulatory strategy from the ground up — before costly assumptions become structural problems.
SaMD & Digital Health Companies
Software and AI-driven product teams navigating the specific requirements for Software as a Medical Device across EU MDR, UKCA, and FDA frameworks.
SMEs Entering New Markets
Established companies expanding into EU, UK, or US markets who need expert guidance on new regulatory frameworks and localised compliance requirements.
Founders Without In-House Regulatory Teams
Founders and technical leads who need a trusted regulatory partner to fill the gap — providing the expertise of an in-house team without the overhead.
Whether you are pre-market, preparing for certification, or scaling into new markets — Regvo provides the structured support you need at every stage.
Who We Help
A trusted specialist regulatory partner
Deep regulatory expertise
Over a decade of hands-on medical device regulatory experience, across multiple device types, markets, and certification pathways.
Founder-focused delivery
We understand the pace, budget constraints, and strategic pressures of building a MedTech company. Our support is designed to fit your reality.
Clear communication
Transparent advice, honest recommendations, and plain-language guidance — without the jargon that slows decision-making.
Practical execution
We focus on what is required for compliance and what actually moves the needle — cutting out unnecessary complexity and bureaucratic overhead.
Direct collaboration
You work directly with experienced regulatory expertise — no layers, no handoffs, and no loss of context between conversations.
Continuity of support
Regvo is built to support clients across the full certification journey, not just the first stage. We are your regulatory partner for the long term.
Regulatory decisions made in the early stages define the entire certification journey. Getting expert guidance from the outset reduces risk, avoids rework, and gives your team the confidence to move forward.
How It Works
Discovery call
We understand your product, market, regulatory stage, and goals — then assess the best way to support you.
Clear proposal
You receive a defined scope, timeline, and deliverables — so you always know exactly what you are getting and when.
Structured execution
We deliver the work in a structured, transparent, and efficient way — keeping you informed at every step.
Ongoing support
Regulatory journeys extend beyond individual projects. We provide continued support as your product and compliance needs evolve.
No surprises. No black boxes. Just clear, expert guidance.
A few words about our founder
Natalia Szychulska
Founder & Regulatory Affairs Specialist, Regvo
Natalia brings over 10 years of experience in medical device regulatory affairs, gained across a range of device types, markets, and business stages. Her expertise spans regulatory strategy, device classification, technical documentation, and compliance support across EU MDR, UKCA, and international regulatory frameworks.
Throughout her career, Natalia has supported companies navigating complex regulatory environments — including startups entering the market for the first time and established organisations transitioning to new frameworks. Her approach combines deep technical knowledge with a practical, outcome-focused mindset.
Regvo was founded with a clear purpose: to give medical device innovators access to expert regulatory guidance that is structured, clear, and proportionate to their stage — so they can move through regulation with confidence rather than uncertainty.
"I built Regvo to give medical device companies the kind of support I always wished was more accessible — practical, structured, and genuinely tailored to where you are in the journey. Depending on the scope of each project, I bring in trusted specialists from my network to make sure every client gets exactly the right expertise."
A flexible network of regulatory expertise
Regvo operates through a specialist consultancy model that brings together the right expertise for each project. Depending on the scope and complexity of your regulatory needs, Regvo may collaborate with trusted specialists across key areas of medical device compliance.
Clinical Evaluation
Access to specialist support for clinical evaluation reports and clinical evidence strategies where required.
Quality Systems
Collaboration with quality management specialists for ISO 13485 implementation and QMS development.
Risk Management
Expert input on ISO 14971 risk management processes and documentation aligned to regulatory requirements.
Technical Documentation
Structured support for technical file and design dossier preparation across EU MDR and UKCA requirements.
Regulatory Strategy
In-depth pathway analysis, market entry planning, and regulatory roadmap development for complex device types.
SaMD & Digital Health
Specialist understanding of Software as a Medical Device requirements and the evolving digital health regulatory landscape.
Regulatory Guides
Practical guidance for founders and manufacturers entering EU and UK markets.
How to Find the Right Regulatory Help for Your Medical Device
What kind of support do you actually need — and when? A practical breakdown of your options.
Read guideDo You Need a UK Responsible Person? (2026 Guide)
Who legally needs a UKRP, what they do, and how to choose the right one for your device.
Read guideRegulatory Strategy for Medical Device Startups
How to build a lean regulatory plan that keeps you on track without burning your runway.
Read guideReady to move forward with regulatory confidence?
Whether you need initial classification guidance, a full regulatory strategy, ongoing consulting, or team training — Regvo is here to help. Book a discovery call and take the first step with a trusted regulatory partner.
Book a discovery callGet in Touch
Have a question about your regulatory pathway, or want to discuss working together? Reach out directly.