GENERAL BUSINESS INFORMATION CERTIFICATION APPLIED: ISO 13485GDPMDFull Conformity AssessmentConformity Assessment by Way of VerificationISO 9001 COMPANY NAME: REGISTERED ADDRESS: COMPANY LEGAL NAME & TRADING NAME (IF APPLICABLE): FURTHER DETAILS OF YOUR PARENT OR GROUP COMPANY, IF ANY: ESTABLISHMENT LICENCE NUMBER: COMPANY TOP MANAGEMENT: NUMBER OF DIRECTORS: POINT OF CONTACT NAME: DESIGNATION: EMPLOYEE DETAILS: TOTAL FULL-TIME: TOTAL PART-TIME: TOTAL SUB-CONTRACTED STAFFS REPORTING TO YOU: LANGUAGE /S: COMMUNICATION: DOCUMENTATION: MEDICAL DEVICE DETAILS SCOPE FOR ISO 13485/GDPMD/CONFORMITY: No Class & Rule Name of Medical Device Intended purpose/use and description Grouping (Single/Set/Family/ System/Testkit/Cluster) Support Files 1 2 3 4 5 COMPANY KEY PROCESSES AND ACTIVITIES: DO YOU OUTSOURCED OR SUBCONTRACTED ANY OF YOUR ACTIVITIES? IF SO, PLEASE DETAIL: DETAIL ANY APPLICABLE LEGISLATION AND/OR STANDARD(S) YOU WORK TO: HAVE YOU ENGAGED ANY CONSULTANT/S? IF SO, PLEASE DETAIL: EXPECTED AUDIT DATE : IF MORE THAN ONE OFFICE LOCATION PLEASE DETAIL NUMBER OF EMPLOYEES AT EACH LOCATION AND THE ACTIVITY BEING PERFORMED AT EACH LOCATION (THIS IS ONLY REQUIRED IF YOU WANT THESE SITES CERTIFIED): We as the company above hereby declare that the above furnished details for the purpose of audit, assessment, and verification are correct at the point of the submission made. In case of any changes to the company ownership, processes, activities and legally reporting situations, we will keep you informed even after getting the service done by AQCTA. SSM Certificate * Organization Chart * Medical device Product certificates (if any) Others if any
