In the fast-moving realm of medical device documentation, precise and clear communication is essential, along with adherence to Regulatory standards. Embracing the Darwin Information Typing Architecture Extensible Markup Language (DITA XML) can revolutionize how you create, organize, and distribute vital information. To create technical content, you need to keep in mind some key pointers that will help you optimize your information.
Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial applications. To address these scenarios, the EC, the Heads of Medicines Agencies (HMA), and the EMA proposed a new initiative entitled, “Accelerating Clinical Trials in the EU (ACT EU).”