Our services
Our commitment to quality and reliability is built on a solid foundation of standardized packages. But the real difference comes in our customized solutions, where our expertise is put to work to find custom-tailored solutions to meet your specific needs.
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In this vein, you can see a fascinating image created by artificial intelligence. Showcases the passion and accuracy with which scientists pursue innovative ideas.
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A perfect symbol of our mission to work with you to achieve extraordinary results.
Standardized packages
Our standard services are designed to meet the typical requirements and needs of the medical device market. To ensure that our services deliver what is most commonly required in the industry, we follow common standards and best practices.
MDR
Manufacturers of medical devices are subject to the European Medical Device Directive (MDR).
From gap analysis and technical documentation to successful certification and post-market surveillance, we can help you meet these requirements.
Our expertise ensures that your products reach the European market quickly and safely, and remain compliant at all times.
FDA
The U.S. Food and Drug Administration's (FDA) requirements for medical device manufacturers are comprehensive and complex.
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From strategic planning and conducting clinical evaluations to preparing 510(k) or premarket approval (PMA) submissions and long-term regulatory compliance, we can guide you through the entire regulatory process.
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Regulatory Document Update
Regulatory documentation requirements are constantly evolving. To ensure that your documentation is always up to date, we monitor these changes for you.
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We ensure that your documentation remains accurate, reliable, and fully compliant, whether it is technical documents, clinical evaluations, or quality management documents.
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On-site audits
The U.S. Food and Drug Administration's (FDA) requirements for medical device manufacturers are comprehensive and complex.
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From strategic planning and conducting clinical evaluations to preparing 510(k) or premarket approval (PMA) submissions and long-term regulatory compliance, we can guide you through the entire regulatory process.
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Tailor-made solutions for complex challenges
Our extensive network of highly qualified experts is available to assist you with your specific medical technology needs. We aim to understand your specific needs, provide in-depth analysis, and deliver customized solutions.
Here is an excerpt from what we can do for you
Clinical trials
Through our network of experts, we enable the performance of validated tests – whether directly on the patient model or under controlled laboratory conditions.
Expert interviews
We organize and conduct interviews with experienced professionals from the medical technology industry. They can provide you with valuable insights into trends, technologies
Technology assessment
Our experts will analyze the latest trends and technologies in the medical device industry and help you integrate them into your product portfolio.
Feasibility studies
We examine new ideas and technologies for their technical, economic and regulatory feasibility.
Development of new products
Taking into account regulatory requirements, we guide you from the concept phase through prototyping to market readiness.
Optimization of existing products
Whether it is quality, safety, or market access, our experts can evaluate your current products, identify opportunities for improvement, and help you implement them.
International market access
We can help you comply with country-specific requirements and provide advice and assistance in getting your products approved for international markets.
Interim management
We can provide experienced managers or project managers to take on operational and strategic tasks when you need them at short notice.
Compensate for capacity bottlenecks
Lacking internal resources? We can provide you with experienced experts who will help you move your projects forward in an efficient manner.
Your ideas count. If you have something specific in mind or special requirements, we are happy to help you. Together we will develop a solution that meets your expectations.
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