Take Your Medical Device from Concept to Approval
Smarter, faster, and safer, with proven regulatory strategies
for the medical device industry.
Stefan Hund
CEO, AssureYou
Evoleen Access provided invaluable support in developing our regulatory strategy and implementing a robust QMS tailored to our medical device distribution needs. Their expertise ensured a smooth compliance process!
Dr. Anjali Raja Beharelle
CSO, Collabree
Evoleen Access provided instrumental support in defining our regulatory strategy, particularly in determining the right regulatory designation. Their expertise as a regulatory sparring partner and in QMS implementation helped us navigate compliance with confidence and efficiency.
Oliver Felix
CEO, docjo
Evoleen Access took a pragmatic approach to streamlining our QMS. Their expertise was fundamental in preparing and supporting our team to achieve ISO 13485 certification in a short time, while also setting up a regulatory strategy tailored to our objectives. Additionally, their mentoring of our Quality and Development staff is providing long-term value, strengthening our internal capabilities.
Alberto
Head Regulatory & Quality, CITUS
Evoleen Access guided us in establishing the foundation for our ISO 13485-compliant QMS while also providing valuable regulatory insights to support our success.
Lyle Halliday
CTO, DigeHealth
Evoleen Access understood our startup’s unique needs, offering tailored regulatory guidance and hands-on support.
Who This Is For
Medical device startups - particularly those led by innovative founders and CEOs who are navigating the maze of EU regulatory requirements for the first time.
Your product is promising, but your internal team lacks regulatory depth. You’re somewhere between funding rounds, budget-conscious, and under pressure to show progress without wasting runway.
You’re not looking for high-level strategy decks or vague consultancy. You need clarity, speed, confidence, and execution.
Let’s be honest. Getting a medical device approved in the EU has never been more confusing - with new rules, shifting standards, and constant updates from every direction.
You know that without the right QMS, regulatory pathway, and strategic guidance, you could be heading in the wrong direction - wasting time, money, and credibility.
To get your device to market successfully, you need a clear, tailored regulatory strategy - one that fits your product, budget, and strategic risk position.
Here are the principles that transform the journey:
01: Start With Strategy
Choose the right regulatory pathway early. The strategy you set today will define your development timeline, required documentation, and budget.
02: Clarity = Speed
Uncertainty is the biggest killer of momentum. A clear plan lets you focus on what matters - funding, development, and market validation.
03: Lean QMS Wins
You don’t need a monster system. You need a compliant, minimal, effective setup that’s proportionate to your stage and risk profile.
04: Invest in Knowledge Transfer
The right external help won’t create dependency - it will upskill your team and leave you stronger.
05: Smart Budgeting
Know exactly where your regulatory spend is going. Plan for every cost, from initial regulatory planning to final approval.
You don’t need more complexity - you need practical clarity and a smart, staged plan that builds confidence across your team and investors.
Evoleen Access is the fastest, highly reliable way for medical device startups to gain regulatory clarity and build investor-ready foundations.
We offer modular support packages - from lean QMS implementation to full strategic oversight - all led by senior professionals who combine regulatory expertise with startup empathy.
Get a step-by-step roadmap tailored to your device.
Build a lightweight, compliant QMS without over-engineering.
Train your junior team and avoid brain drain.
Access real-world advice grounded in your business context—not textbook theory.
Align your regulatory strategy with your GTM and funding milestones.
Engineer | Regulatory | Medical Device | Entrepreneur | ISO 13485 | EU | 🚴
Michael
Michael is a seasoned medical device professional with over 18 years of experience in development, regulatory affairs, quality, and project management. He excels in leading teams to navigate the complexities of bringing innovative healthcare products to market in both startup and corporate settings. His mission is to help healthcare companies launch products while understanding overall strategy and risk. Michael, a certified lead auditor for ISO 13485, has been instrumental in commercializing numerous medical devices.
Regulatory Affairs | Quality Management | Medical Devices | ISO 13485 | EU | APAC | Startup | 🤘🏻
Chregu
Chregu has extensive experience in regulatory affairs and quality management/assurance from Class I to III and active implantable medical devices with European and APAC competent authorities in startups and multinational corporates. When Chregu is in focus mode he is in focus mode, and only if you deplug his headphones there might be a chance of him noticing your appearance.
Medical Device & Pharma | Regulatory Compliance | Quality Management | Global Launches
Eva
Eva is a seasoned medical device professional with 20 years of experience in start-ups, mid-size and global medical technology and
pharma companies. She excels in assisting your project to navigate the complexities of understanding and complying with regulatory requirements for product development. Her mission is to contribute to deliver impactful solutions for safe and effective devices. Eva has been instrumental in successful market launches.
Case Studies
You don’t need to figure this out alone - and you shouldn’t waste another month spinning your wheels.
👉 Book a free clarity session with one of our senior consultants. We’ll map your current position, highlight gaps, and recommend your next best steps—no obligation, no sales pitch.
This one conversation could save you 6–12 months of wasted time and thousands in avoidable costs.