The interpretation of ISO 13485 is rarely easy, and even more rarely unambiguous. There is also an almost endless number of ways in which the requirements can be implemented. In this forum we discuss these interpretations and implementation options, their advantages and disadvantages. We are open to new or different ideas and do not stick to our opinions if they are not justified objectively. We discuss with respect and appreciation. If I learn something from the contributions that I would like to include in the book, I will of course ask for permission and will credit the author accordingly in the book. Otherwise: happy discussion! Sincerely yours, Andreas