Shaping global standards in clinical research
We are proud to announce that Caroline Schmidt-Lucke has been appointed as an expert to the international committees ISO/TC 194 and NA 027-07-20 AA for "Clinical Investigations" (ISO 14155). Our goal is to open doors for innovative clinical trials based on established standards.
The updated ISO 14155:25 standard sets the global benchmark for clinical investigations of medical devices and digital health applications. ISO/TC 194 standardizes approaches for biological and clinical evaluation of medical and dental materials and products, including development of biological test methods and principles of good clinical practice for clinical investigations on humans. It plays a key role in ensuring high-quality clinical data and supporting safe, reliable market access in Europe.
Close collaboration with global experts will drive innovation and consistency in the European market while strengthening trust and cooperation between manufacturers, partners, and regulatory authorities worldwide.
Demonstrate the medical benefits of your product
With our many years of experience and expertise, we offer effective solutions to show the medical benefits of your product.
From conception to implementation of preclinical and clinical studies, we support you with tailor-made services.
Find out how MEDIACC can help you get your products refunded.