3.10 Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized. 3.11 Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system. 3.12 Medical device including substances used for in vitro diagnosis referred to in rule 3 of these rules.