About Us
From Complexity to Clarity –
for Safer Healthcare
VYSYO is an international consulting firm based in Düsseldorf. We help life sciences companies bring their innovations to market quickly, safely, and successfully.
Our focus is on:
- Quality & Compliance – robust systems that pass audits and inspections
- Regulatory & Market Access – Approvals in Europe, the U.S., and Asia, and reimbursement by payers
- AI and Artificial Intelligence – We use AI to make evidence available more quickly, accelerate regulatory processes, and support clinical decision-making
- Clinical Evidence – Planning and conducting clinical trials in accordance with ISO 14155 / GCP
- HTA & Medical Affairs – From evidence assessment to communication with physicians and stakeholders
Our Mission
We translate regulatory requirements into clear strategies. We combine medical evidence with market access. We ensure reliability in terms of budget, timeline, and quality. In short: We bridge the gap between innovation and patient access.
Our Approach
- 360° Perspective: With VysyoAccess360™ and VysyoPath360™, we examine all dimensions—regulatory, clinical, and economic.
- Physician’s Perspective: Physicians, scientists, and regulatory and market access experts bring diverse perspectives to the table—to develop solutions that ensure compliance and deliver real clinical benefits.
- International & Connected: Projects in Europe, the U.S., China, India, and South America—global reach, global expertise.
About the founder:
Dr. Kai Ulf Markus – physician, entrepreneur, and founder of VYSYO. With many years of experience in cardiology, clinical research, and regulatory affairs, he supports companies by serving as a bridge between medicine, regulation, and the market. Known on LinkedIn for his combination of thought leadership, clear stance, and personal commitment, he connects decision-makers worldwide.
‘Medicine is always international. Its products should be too. This is not only because their commitment should pay off, but also because I believe that as many patients as possible around the world should benefit from good medicines and products.’
Dr. Kai Ulf Markus
‘Medicine is always international. Its products should be too. This is not only because their commitment should pay off, but also because I believe that as many patients as possible around the world should benefit from good medicines and products.’
Dr. Kai Ulf Markus
What are the advantages of working with us?
All of our team members are experienced…
- from medicine, medical science or related industries.
- with the development of products and medicines.
- manufacturing products and medicines.
- with the approval and distribution of products and medicines.
We understand the demands of highly competitive, conservative and price-sensitive global medical care markets.
Our team includes physicians, engineers and biotechnologists
We have the above expertise distributed throughout the team and in some cases in combination. Our team is made up of highly experienced people who are experts in product registration and who understand the QM requirements for medical devices.
They also know from experience (and not just theory) the processes in an innovative company and among users.
Outsourcing of QM and RA activities
Why Vysyo? Why outsourcing?
Is your company’s core area really licensing, QM and regulatory compliance?
The market is becoming increasingly complex and heavily regulated, with all the associated pros and cons. We do not view this negatively: regulations in the healthcare sector often provide greater security and, above all, establish objective benchmarks for your portfolio’s performance.
What has long been standard practice in many successful companies is also increasingly true of quality and regulation: the best companies focus on their core business and outsource everything else to proven experts.
In particular, our most innovative and agile customers rely on us — a powerful team of experienced professionals who support them competently and efficiently, on an equal footing.
Here are eight compelling reasons to work with us:
Regulatory affairs that make a difference: Vysyo helps you to navigate national and international requirements safely, designing efficient, clear and targeted approval processes to give you direct market access.
Strategy with vision: We support you beyond the approval stage, providing well-thought-out planning, networked thinking and a clear roadmap for your products, covering pricing, reimbursement and strategic marketing.
QM that works: We develop lean, audit-proof quality management systems that are perfectly tailored to your processes, ensuring maximum acceptance and test reliability.
Confidently through every audit: Whether it’s an inspection or a partner audit, with Vysyo you will be optimally prepared and able to present your company to the outside world with confidence.
Reach your goal faster: With Vysyo, you can save time, resources and stress thanks to accelerated processes, fewer errors and faster market entry.
Approval and reimbursement are key to success. We start with regulatory support and also provide pricing, reimbursement and health economics support to ensure long-term market success.
Solutions tailored to you: No standard solutions, no copy-and-paste. We offer customised concepts that are perfectly tailored to your products, structures, and challenges.
Reliability that lasts: Vysyo is not just a service provider — we are your long-term partner. We are transparent and solution-oriented, and we always work with you at eye level, using our heart, mind and experience.