An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often,...
Expertise: MedTech 32 results
Clinical Development
Nicole Sativtsky
MedTech
Heidi Boehm
MedTech
Frank Keulen, M.Sc.
Women's Health
Charlie Chrisawn
Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions.
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition...
If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this resource...
There are currently more than a dozen categories of female birth control with proven efficacy on the market. For men, the only options available today are condoms and vasectomy. Despite decades of research and discussion about male contraception, no new...