A medical devices manufacturer developed a Class III device to treat a certain type of cancer. The device was designed to use a very specific reagent. The company wanted to develop expand their presence in Europe with this new product and therefore was obligated to apply for a CE mark.
A medical devices company encountered the opportunity to acquire their first technology license and needed to understand their different regulatory compliance obligations prior to acquisition. The technology has been used for years globally, thus there was a large amount of clinical data related to the acquisition of the license.