Wasela Diagnostics

About Wasela Diagnostics

Wasela Diagnostics is a leading regulatory consulting firm specializing in In Vitro Diagnostics (IVD) devices. With 17 years of FDA regulatory experience, we provide expert guidance to navigate the complex landscape of medical device regulations. OUR SERVICES - FDA submission preparation (PMA, DeNovo, 510(k), Pre-submission, EUA, Breakthrough designation) - Regulatory strategy development - Companion diagnostics applications - Gene therapy applications, regulatory support AREAS OF EXPERTISE - In vitro diagnostics regulation - Viral and microbiological device development - Molecular diagnostics - Serological devices - Laboratory Developed Tests (LDTs) - IVD Analytical and clinical studies design and analysis - Employee/staff regulatory training WHY CHOOSE WASELA DIAGNOSTICS? Our team's deep understanding of FDA requirements and extensive experience in the IVD regulations allows us to provide tailored solutions that streamline the regulatory process for our clients. Whether you're developing a new diagnostic tool or seeking to optimize your regulatory strategy, Wasela Diagnostics is your trusted partner in achieving compliance and market success. VIRTUAL CONSULTATIONS We offer convenient virtual consultations to meet the diverse needs of our clients. Our remote services ensure that you can access our expertise regardless of your location, allowing for flexible and efficient collaboration on your regulatory projects. Partner with Wasela Diagnostics to leverage our expertise and accelerate your path to market while ensuring regulatory compliance!

View contact profiles from Wasela Diagnostics