Medical Devices

Abstract

· The course provides an overview of the most relevant classes of medical devices such as orthopaedic, dental and cardiovascular implants.· Distinction between medical devices, drug products, and combination products is made, particularly with respect to regulatory requirements.

Objective

• Basic knowledge of medical devices, their fabrication, properties and application. • Understanding the specificities of medical devices and their regulation. • Present the life cycle of a medical device including treatment options, market environment, device design and regulatory aspects.

Content

Mechanical function, material properties and surface conditions are key issues of most medical devices. The mechanical function will be a focus of the lectures on artificial joint replacement, dental implants and the treatment of bone fractures. The different classes of materials used in medical devices - ranging from permanent metals to degradable ceramics and polymers - will be presented. The importance of surface conditions for implant-related infections will be discussed. The market and regulatory environment for medical devices will be compared to the pharmaceutical field.

Resources