Harnessing real-world data: An advantage for medical device manufacturers
Crispin Bennet, Heidi Chapman and Laura C Collada Ali of Trilogy Writing & Consulting explore how it’s time for medical device manufacturers to harness the full potential of real-world data...
Episode 40: The CDX files: Decoding Companion Diagnostic Devices
This episode of TriloTalk explores companion diagnostics and what makes them medical devices. Join Julia Forjanic Klapproth, Senior Partner at Trilogy, Laura Collada, Senior Medical Writing Manager at Trilogy, and Raquel Billiones, Director...
The role of real-world evidence in post-market clinical follow-up
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,...
Real-world data coming into play in the medical device world: What medical writers need to know
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...
Episode 37: Primer on Writing for Drug-Delivery Systems
TriloTalk episode 37 focuses on a specific type of medical device, the drug-delivery system. Writing for drug-delivery systems is all about being fluent in two languages – drugs and devices....
Episode 33: Are Medical Devices from Venus and Pharmaceuticals from Mars? Important things to know when writing for medical devices.
This episode focuses on writing for medical devices. Playing Sherlock Holmes, conducting usability studies, following regulations, working closely with the manufacturers and much more are all in a day’s work...
The Clinical Evaluation Report: Document Writing and Compilation
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...
The Clinical Evaluation Report: Bringing it Together
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...
