ABSTRACT
This chapter states the challenge that all medical device companies must meet. Compliance is essential, but regulations and standards are changing all the time, so quality management systems must keep up with the changes. The chapter enumerates the key developments around the world. The chapter then describes country by country and region by region the documents that apply to qualitymanagement systems for medical device companies. It then discusses other requirements that companies may want to establish and also touches on the situation from the perspective of the employee. It finishes with a quality and regulatory perspective.
