Sterile Safequip and Chemicals LTD

Conformity Check – Devices comply with QMS requirements before release. Documentation – Technical files and the EU Declaration of Conformity are maintained and updated. Post-Market Surveillance – Obligations under Article 10(9) are met. Regulatory Reporting – Reporting duties in Articles 82–86 are fulfilled. Performance Studies – Statement under Annex XIV, Section 4.1 is issued for high-risk studies.