"The secret to getting ahead is to take one step-we'll show you where it leads*".
* Mark Twain 1835 - 1910
OUR VISION
We see ourselves as a company that can help medical device companies improve the efficiency and affordability of their products. By doing so, we create solutions that optimize processes and accelerate the achievement of your objectives.
Our services
Our services are based on a flexible model of standardized packages and customized contract work. We tailor each project precisely to your needs. To mitigate risk, we emphasize a clear definition of expectations and objectives - for customized solutions that deliver.
MDR
From development to approval: Reliable, comprehensive, and competent, we provide everything you need to meet MDR requirements.
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FDA
Stay on top of FDA regulations with us. We can help you get approved in the U.S. by providing comprehensive expertise and customized solutions.
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Regulatory Document
Update
We continually and proactively update your documentation booth by monitoring changes in MDR and FDA regulations.
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On-site audits
Our on-site audits assess your readiness to comply, identify areas for improvement, and support your compliance efforts.
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Consulting
We help with gap analyses, product development and general questions.
With our network of experts, we offer tailor-made solutions.
Our network
We can solve even the most complex challenges for medical device manufacturers with our global network of renowned institutions and leading experts. The tougher the challenge, the more we get excited about solving it.
Prof. Dr. Belir Atalay, PhD
Specialist in ceramic and titanium implant systems, Professor of Oral, Maxillofacial and Facial Surgery at Istanbul University
Our way of working: Understandable, transparent and ethical
Our way of working is based on three essential pillars: a deep understanding of the project, complete transparency and clear objectives, always guided by our core ethical principles. We aim to make every project sustainable, to ensure that what we do creates long-lasting positive change.
Understanding our mission
Sustainable results begin with a clear understanding. That's why we have a deep understanding of the business and the challenges at hand. In doing so, we ask as many questions as necessary - persistently, precisely and, if necessary, multiple times.
Communicate clearly and bindingly
An open line of communication is very important to us - even when it comes to pricing. Our prices are transparent and easy to understand. Daily rates start at 600 euros and vary depending on project requirements and the expert knowledge required.
Thinking and Acting Ethically
Unethical practices or procedures have no place with us. We are committed to working responsibly and sustainably to help improve the way we live.
selection of customers
