Let's unlock Market Access -
we handle the Regulations, you drive Innovation
We are part of Evoleen's ecosystem
We offer tailored regulatory and quality solutions for our Medical Device Clients.
Got a quick regulatory question about your medical device?
Let’s clear it up in a free 30-minute consultation - no strings attached.
Our Services
REGULATORY
Targeted guidance for digital health and MedTech startups, ensuring compliance with EU (MDR/IVDR) and US FDA regulations.
Offering a comprehensive solution that includes regulatory strategy, gap assessments, remediation, project management, and direct interaction with authorities and notified bodies. tailored approach that addresses startup-specific challenges often overlooked by generic consultancies
QUALITY
Establishing lean Quality Management Systems in compliance with ISO 13485 and US FDA’s Quality System Regulation (21 CFR 820)agile approach, identifying gaps and implementing continuous improvements to meet the unique needs of your startup.tailored solution optimized for your situation (from manual QMS to fully digital eQMSs)
Mentoring your internal resources to get independent from external support
TECHNICAL DOCUMENTATION
Establish or support the creation of Technical Documentation compliant with EU MDR IVDR Annex II and FDA CFR 820.
Custom-crafted to your unique innovation, beyond just templates.
Close collaboration to translate complex data into clear, regulator-friendly language.
This comprehensive approach accelerates approvals and sets the stage for market success.
EU AUTHORIZED REPRESENTATIVE SERVICE
Our EU Representative service offering a reliable local presence in Munich for seamless European market entry.
Direct communication with EU authorities, ensuring MDR and IVDR compliance.
Proactive resolution of compliance issues with a global perspective, including US market insights.
Ensures smooth entry and continuous regulatory adherence across regions.
Who we are
At Evoleen Access, we are more than just a consultancy—we are part of a Evoleen's ecosystem focused on scaling disruptive digital health solutions and smart medical devices. We understand the unique challenges startups face and offer expert regulatory affairs, quality, and technical documentation services to help navigate EU MDR/IVDR and US FDA requirements. With a hands-on, tailored approach, we accelerate market entry and ensure compliance, so your innovation can thrive. Our expertise is available not only for our own ventures but also for any digital health startup looking for strategic support to drive success in a complex healthcare landscape.We offer our knowledge, services, and technologies to any interested digital health start-up. Our ultimate mission is to solve significant healthcare problems and provide global access to quality care. With dedicated ventures and scalable solutions, we are driving meaningful change in healthcare, one innovation at a time
Engineer | Regulatory | Medical Device | Entrepreneur | ISO 13485 | EU | 🚴
Michael
Michael is a seasoned medical device professional with 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.
Why Choose Us
Evoleen Access was created to empower Evoleen’s own startups with expert knowledge and seamless execution in regulatory affairs and quality. Now, we offer these specialized services to external startups, giving you more than just consultancy. As our client, you gain full access to the complete Evoleen ecosystem—software development, market validation, ideation, and distribution services—all tailored to accelerate your success. We are not a typical QA/RA consultancy; we speak the language of MedTech startups because it’s in our DNA, helping you navigate challenges and scale your innovation faster
Testimonials
Trusted by Startups, Backed by Success
James Creeden, MD, PhD, Co-CEO,
CGC Genomics
Evoleen Access provided regulatory assessment and strategy for our sophisticated AI software product, helping us navigate the key regulatory landscape. While implementing a tailored QMS, their invaluable mentorship is crucial in guiding our team through the process.
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!
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.
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.
Chris Gugl, Co-Founder & CEO
Evoleen AG
Evoleen Access serves as the regulatory authority within Evoleen’s ecosystem, ensuring compliance and strategic guidance for all medical device startups. Their expertise provides a strong regulatory foundation, allowing ventures to navigate requirements efficiently and focus on innovation.
Dr. Anjali Raja Beharelle, CSO
Collabree
Evoleen Access provided invaluable 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.
James Creeden, MD, PhD, Co-CEO,
CGC Genomics
Evoleen Access provided regulatory assessment and strategy for our sophisticated AI software product, helping us navigate the key regulatory landscape. While implementing a tailored QMS, their invaluable mentorship is crucial in guiding our team through the process.
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!
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.
Chat with us
Our team is here to help you
access@evoleen.com
Visit us
Drop in for a coffee chat
Evoleen Access GmbH
Kochelseestr. 8-10
81371 Munich, Germany