Performance Evaluation Report (PER): Requirements, Process, and Best Practices
Author: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology The Performance Evaluation Report (PER) is one of the most critical technical documents required […]
EU MDR and Clinical Evaluation Reports
Author: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology If your company is planning to market a medical device in the European Union, […]
Designing a Systematic Literature Review (SLR) That Serves Both Regulatory and Commercial Goals for Pharmaceutical Companies
Systematic Literature Reviews (SLRs) have long been recognized as essential to regulatory submissions. Yet their true potential extends far beyond compliance. When designed with foresight and methodological rigor, SLRs can […]
