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