EU MDR · UKCA · ISO 13485 · Asia

Medical software
certification —
from start to CE mark.

We embed with your team and take you from gap analysis to CE mark — across EU, UK, and Asia. 15+ startups certified, 100% audit success rate.

Lizaveta Dabrynskaya
Lizaveta Dabrynskaya
Founder & Regulatory Consultant · 13+ years
"Delivering trust and traceability at every point of care"
ISO 13485 EU MDR AI/ML SaMD UKCA QMS from 0→1
15+ Medical software startups certified
100% Notified Body audit success rate
50M€+ Funding raised by our clients
6–12 Weeks average timeline
3 Global markets: EU, UK, Asia

Your Pathway to Certification

A structured, transparent journey from concept to market access — guided by experts across Asia, UK, and EU.

01
🔍
Discovery & Scoping
We analyze your medical software, classify the device, define the intended use, and outline regulatory pathways (EU MDR / UKCA / Asia) with a clear roadmap.
02
📋
Gap Analysis & Strategy
Deep-dive into technical documentation, QMS, and risk management. Identify gaps against ISO 13485, IEC 62304, IEC 62366, ISO 14971 & MDR Annexes.
03
🔧
Implementation & Build
Hands-on creation of compliant technical documentation, SOPs, clinical evaluation plans, AI/ML validation, and software lifecycle processes.
04
✅
Audit Readiness
Pre-audit mock assessments, internal auditor training, and complete preparation for Notified Body or competent authority interactions.
05
🤝
Regulatory Body Support
We accompany you during official audits, manage technical clarifications, and coordinate with your chosen NB or Asian regulatory bodies.
06
🌍
Certification & Beyond
Achieve CE/UKCA/Asia market approvals, maintain post-market surveillance, and scale your global footprint with ongoing regulatory lifecycle support.

Full Compliance Expertise

End-to-end coverage across all major medical software and device regulations — so you never have to coordinate between multiple consultants.

ISO
ISO 13485
Quality Management System — the foundation of every medical device certification
EUUKAsia
ISO
ISO 14971
Risk Management — systematic process for identifying and controlling product risks
EUUKAsia
IEC
IEC 62304
Software Lifecycle — development, maintenance, and retirement processes for medical software
EUUK
IEC
IEC 62366
Usability Engineering — ensuring software is safe and effective in real clinical use
EUUK
IEC
IEC 81001
Health Software Security — cybersecurity requirements for health software products
EUUK
IEC
IEC 82304
Health Software Products — general requirements for standalone health software
EUUK
MDR
2017/745
EU MDR — CE Mark regulation for medical devices and Software as a Medical Device
EU
AI/ML
AI Regulation
Artificial Intelligence — validation, explainability, and algorithm compliance for AI-based SaMD
EUUKAsia

What our clients say

She takes her job seriously and always approaches problems in a systematic way. Always there to clarify requirements and offer assistance no matter the hour.

Patrik Glavica
Security Master & Team Lead · Ericsson Nikola Tesla

Her work ethics are of the highest order — always on top of tasks, very proactive, well organised and willing to help. She has my highest recommendation.

Andrei Zemliakou
Director, Compliance Assurance · EPAM Systems

Lizaveta is very knowledgeable in her field and open to learning new things. She is organised and won't let go until project results are achieved with success.

Sherif S.
Business Development Manager

In 2–3 weeks she started defining full modules by herself, exceeding personal goals every time. Competent, calm, organised — excellent potential and a great team player.

Marko Kranjčić
Technical Coordinator · Ericsson Nikola Tesla

I cannot emphasise enough how big Liza's contribution was on our national healthcare information system. Top professional, remarkable attention to detail. Cannot recommend her enough.

Zvonimir Planinc
Solution Manager · Ericsson Nikola Tesla

Together we developed SaMD and obtained Malaysian GDPMD/MDA certificates. Lisa guided the entire team, assisted with usability risk management and documentation. Highly skilled and a pleasure to work with.

Alex Nosach
Senior UX/UI Designer

Lizaveta explained what we were working on across multiple SaMD certifications. She conducted training sessions, presented demos to the client and managed documentation. The client feedback was excellent.

Stanislav Khytrych
Software Architect & Lead Frontend Dev

Only thanks to Liza's guidance did we successfully obtain ISO 13485/9001 and MDA certifications for the Malaysian market. Her attention to detail and proactive approach ensured all compliance goals were met.

Vitali Birchanka
Lead BA/SA in Healthcare, Product Manager

Start Your Certification Journey Today

Book a free 30-minute strategy session. We'll analyze your current status and provide a clear roadmap to certification across Asia, UK, and EU.

Book free strategy call →
No commitment · We respond within 1 business day