Webinar Topics

The 2020 revision of ISO 14155 is a truly transformative regulation that will allow sponsors to run trials anywhere in the world. By following this standard, sponsors will be able to select the best sites for the investigation in any geography and generate data that will be accepted by the US FDA and also by European and Asian regulatory authorities. In fact, the standard has been aligned with the new European Medical Device Regulation, US FDA regulations and global requirements, enabling seamless compliance and removing barriers to scientific progress. This standard is also aligned with pharma requirements and therefore, it’s helpful for trials of combination products.