Notes:
The ISO13485 management system of Advanex Europe excludes the following non-Applicable clauses:
7.3 Design & development - Advanex Europe are notnot the design authority for products supplied for medical devices
7.5.1.3
(2003) / 7.5.5 (2016) Particular requirements for sterile medical
devices - Advanex Europe do not supply sterile medical devices
7.5.2.2 (2003) / 7.5.7 (2016) Particular requirements for sterile
medical devices - Advanex Europe do not supply sterile medical devices
7.5.3.2.2 (2003) 7.5.9.2 (2016) Particular requirements for active implantable medical devices and implantable medical devices - Advanex Europe do not supply implantable medical devices
7.5.3 (2016) Installation activities - Advanex Europe do not supply installation activites
7.5.4 (2016) Servicing activities - Advanex Europe do not supply servicing activites
8.2.3 (2016) Reporting to regulatory authorities - Advanex Europe do not have any applicable requirement to report to regulatory authorities
The AS9100 management system of Advanex Europe excludes the following non-Applicable clauses:
8.3 Design & Development