Astrimmune are currently collaborating with Paraytec to develop a non-invasive test using urine samples to detect bladder cancer, known as Sentinel. The intention is to register this test as a medical device in the EU and USA. Due to the complexity of the US regulations, they want to ensure that they consider all regulatory strategies, select the most appropriate and build this into the product development.
Astrimmune are therefore looking to engage an expert medical device regulatory consultant specifically focused on interactions with the FDA and the US medical device regulations.
For further information, please click here to email Sue Hagan.