To place a medical device on the market, a clinical investigation might be needed to demonstrate safety and performance, including clinical benefits. There are several regulations and guidelines to follow, which we will cover in this webinar. Whether you are a small medtech company or a large one, this webinar is a must-attend for anyone curious about how clinical studies on medical devices are conducted.
- Planning and conducting a clinical study
- When is a clinical investigation needed?
- Different types of clinical investigations and the regulatory pathway in Europe
- Essential documents
- Good Clinical Practice – GCP for Medical Device studies (ISO 14155:2020)
The presenters will be Berit Larsson, a senior consultant in clinical development at SDS MedteQ and Johanna Apro, a senior consultant in clinical project management at SDS Life Science.