Single-Use Sterile Laparoscopic Instruments are categorized in Class IIb as per European Medical Device Directive and as such are subject to a number of rigourous testing and Quality Assurance requirements. Our quality management system complies with the requirements of ISO 13485 and ISO 9001 quality management systems. Production and quality management of our products complies with European Medical Device No 93/42 for CE mark. Below are some salient features of our Quality Assurance Protocol: • Product Technical Files according to Medical Device Directive 93/42 EEC • Manufacturing and assembly in ISO 7, Class 10,000 Clean room as per ISO 14644 • Risk Analysis performed according to ISO 14971. • Clinical Validations performed in accordance with CE requirements. • Electrical Safety Tests performed according to IEC 60601. • All instruments are tested against micro holes/porosities in insulation using Hi Pot tester. • Terminally packaged in sterile barrier system. • Heat Sealing process validation performed as per ISO 11607 standard. • Process Validations for Ethylene Oxide Sterilization performed according to ISO 11135 standard. • Use of Bio-compatible Materials as per ISO 10993 standard. • All instruments supplied with Instructions of Use as per CE mark requirements. • Product Labels in accordance with European CE requirements.