Global Regulatory Writing & Consulting (GLOBAL)的动态

Transcript

So let me present this scenario that we'll be discussing today. In the last few years, Global was approached by a new client with a few unique characteristics. They were a relatively or still are relatively new startup that had several devices that had already been see marked under MD. And while some of the devices in the portfolio had been received, had received approval under MDR, the team was actually working on new products and they were in the midst of preparing for an internal technical review when they approached us. They really needed their documents for. Uh, to be finalized in about six weeks. Not only was this a tight deadline, they also had a very strict budget that they needed to follow. Among the identified challenges at this project presented was of course, that expedited timeline, but also this project comprised an update and remediation of six documents, which included three plans and three reports. Some of their documents had been completed in the years prior but required significant updating the information. It was a little bit unclear and they had new clinical data to incorporate. And so they look to us to make sure that their documents were updated correctly and that the story of their devices was told as clearly as possible. Furthermore, what really increased the challenge of hitting their deadline was what I mentioned just a second ago, a lot of new clinical data.