PRISMA-Compliant Literature Reviews: What “PRISMA-Compliant” Actually Means for Your CER or PER
Author: Sarah Chavez, Director of IVD and Scientific Writing Services For medical device and IVD manufacturers, literature reviews are much more than background research. They are an important component of […]
Data Extraction and Appraisal Tables in Systematic Literature Reviews: What a Notified Body Expects to See
Author: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology For medical device and in vitro diagnostic (IVD) manufacturers, identifying relevant literature is only […]
The Impact of MDCG 2024-10 on Internal Processes, Timelines, and Team Readiness
The introduction of the MDCG 2024-10 guideline in June 2024 marks a significant shift in how orphan medical devices are evaluated and brought to market in the European Union. This […]
