Safety and quality are non-negotiable in the medical devices industry. More and more, organizations are being put under a microscope, expected to demonstrate their quality management processes and ensure best practices in everything they do. At genae, we tap into our wide range of quality and regulatory experience and expertise to guide you through every stage of your clinical project. Download this case study and discover our quality expertise.
The healthcare industry is witnessing many changes in this digital era. A recent revolutionary development in digital health technology is software that can perform complex medical functions - software as a medical device (SaMD). Download this white paper and discover why implementing a regulatory strategy early in the development will go far in bringing you closer to successful market access of your SaMD.
As a sponsor, you are very aware of the unique challenges found in orthopedic trials. When barriers such as design, sample size, and the need for patient-centered outcomes are overcome, evidence from trials can have a positive impact on surgical practice. At genae, we tap into our wide range of orthopedic and spine product experience to guide you through every step of your clinical journey. Download this case study and discover our orthopedic expertise.