AKRA TEAM was founded to solve a growing challenge in the medical device and diagnostic industry: the increasing complexity of regulations and the scarcity of experienced professionals who can interpret and apply them effectively.
Since our founding, we have supported hundreds of successful projects and have been trusted by organizations of all sizes, from start‑ups to established global manufacturers. Our purpose is clear: to deliver a wide range of professional, predictable, and patient-oriented services, and help elevate the overall quality and safety of healthcare technologies around the world.
Former VP, Global Strategic Business Development
TÜV SÜD — Europe’s Largest Notified Body
My years at TÜV SÜD gave me an extraordinary vantage point. I was inside the regulatory machine, shaping guidance documents, sitting on MDR task forces, training stakeholders across the globe. But the more I saw, the more I realized that the device and diagnostic manufacturers on the other side of the table, were often navigating this complexity without the right compass. They needed assistance with truly bringing together both sides: the regulatory expectations and the practical realities of bringing a product to market. I wanted to help build that bridge. AKRA TEAM was born from that conviction.
The timing was deliberate. MDR had just come into full force and IVDR was on the horizon. Manufacturers were under enormous pressure, many of them still struggling to understand what compliance actually looked like in practice. I had spent the previous years helping to write those rules and train people on them. It felt like exactly the right moment to step out and offer that knowledge directly to the companies who needed it most. Not as an auditor reviewing their work, but as a partner helping them get it right.
Manufacturers told me again and again that they were getting generic advice from consultants who could cite the regulation but struggled to translate it into actionable steps for their specific product and situation. What I wanted to offer was something different: deep, specialized expertise that is professional, predictable, and always focused on the patient. Those three words became the foundation of how we work. When a company trusts us with their regulatory pathway, they need to know that what we deliver will be thorough, honest, and ultimately in service of getting safe, effective products to the patients who need them.
It means we understand the full lifecycle; from the lab bench, through the conformity assessment process, all the way to post-market surveillance. I started my career developing medical devices and combination products at a university hospital. That experience never left me. When I sit across from a manufacturer who is passionate about their innovation, I understand that passion. And I also understand what the notified body on the other side of the table will expect to see. That dual perspective is genuinely rare, and it’s something the whole AKRA TEAM brings to every engagement.
Success is a safe, effective product reaching the patient who needs it. Everything else, from the documentation to clinical evaluations, quality systems, etc. is in service of that outcome. For our clients, success means navigating a complex regulatory environment without losing time, resources, or momentum. When a manufacturer comes to us overwhelmed, and leaves with a clear strategy and the confidence to execute it, that is exactly what we built this company to do.
Access Expert Guidance When You Need It Most
In the fast-paced world of medical device and diagnostic manufacturing, challenges don’t arrive on a schedule. Our innovative subscription model gives you dedicated consulting hours at your fingertips – ready when you need them, without the stress of unexpected costs.
Google reviews.
Behind every successful outcome is a team that brings decades of hands‑on expertise. With deep experience supporting complex submissions, audits, and compliance initiatives across multiple jurisdictions, our consultants offer a practical, strategic, and globally informed perspective. This combination of technical skill and real‑world insight ensures that the guidance we provide is trusted, actionable, and aligned with the expectations of regulators and industry alike.
In a landscape where medical device requirements evolve quickly, companies also need advisors who not only understand the standards but help shape them. Our consultants have contributed to international standards development, supported the creation of regulatory guidance, and participate actively in working groups, committees, and professional associations. Their continued involvement at this level ensures our clients receive advice that reflects both current requirements and the direction the industry is heading.
We are proud to bring together professionals who share a commitment to integrity, excellence, and meaningful results. Their dedication to advancing the industry is what truly sets our team apart.
Our clients trust AKRA TEAM for clear, pragmatic regulatory expertise that supports compliant decision‑making across the entire product lifecycle, from market introduction to ongoing safety and regulatory compliance under MDR, IVDR, FDA and beyond.
Founder - Executive Consultant
Senior Managing Consultant
Senior Managing Consultant
Senior Consultant
Senior Consultant
Management Assistant
Senior Consultant
Senior Consultant
Senior Consultant
Senior Consultant
Senior Consultant
Senior Consultant
Senior Consultant
Training and Community Engagement Lead
Senior Consultant
Junior Consultant
Senior Consultant
Quality Manager and Senior Consultant
organizations supported worldwide
combined years of regulatory, clinical, and quality experience
Global expertise across EU, USA, and international markets
Proven track record with high risk, innovative, and novel technologies
Active involvement in regulatory and standards development committees
Deep experience with notified bodies, authorities, and industry best practices
Trust starts with responsibility. A strong sense of ethics guides everything we do including how we handle data and protect privacy, with full transparency set out in our Imprint and Privacy Policy.
Whether you are preparing for a major submission, scaling your internal capabilities, addressing a challenging audit, or entering new markets, AKRA TEAM delivers strategic guidance backed by real‑world experience.
We are here to support your mission and empower your team. If you are ready to bring your device to market efficiently, and with the confidence that every requirement is met, our experts are ready to help.