Topic: Medical Devices

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements,...

The integration of real-world data (RWD) into healthcare decision-making has transformed various aspects of clinical research, regulatory approval, and post-market surveillance. As the healthcare landscape continues to evolve, the use...

Trilogy offers high-end medical writing that goes beyond just making sure a document is structured properly: it involves content-driven sanity checks, a sense of ownership of the documents  and offering...

In light of recent regulations, it is important to discuss the general aspects and strategies for writing and compiling a CER. In Europe, a clinical evaluation report (CER) is now...

Julia Forjanic Klapproth of Trilogy Writing & Consulting GmbH elucidates how it’s time to start using strategic medical writing in the world of device submissions. Until recently, the documents needed...

Gerry McGregor, a principal medical writer at Trilogy Writing & Consulting, explains how experienced medical writers can help medical device manufacturers to meet the new regulatory demands of producing clinical...