Webinar: Clinical evaluation and clinical investigation of medical devices
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.
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.
Content:
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.
