Quality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However, effective QS can help a business not only comply, but excel. This course focuses on medical device companies and how to create, implement, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS, the biggest pitfalls in establishing and maintaining QS, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS, it is definitely true that one size does not fit all!