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Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the … Read more

Pharmaceutical companies that work together with a medical device supplier for their integral drug-device combination need to have sufficient control over the readiness of the required documentation. Especially in the early stages of a project, these matters can be challenging. The checklist can provide an indication of the readiness of the documentation for the device … Read more