(EN) ISO 13485:2016

1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name*
Street*
City /Pincode*
Country*
Website Address
2. ADMINISTRATIVE INFORMATION
Certification Body Interested	Select BSI DARE DERKA DNV DQS GMED UKCERT INTERTEK KIWA NSAI SGS TUV RHEINLAND TUV SUD UNICERT DONT KNOW
Scope of Manufacturer	Select Design, Manufacturer and Sale of Device Manufacturer and Sale of Device Assembly, Packing, Labelling and Sale of Device Manufacturing for Others Design and Testing Service Medical Device Servicing Medical Device Testing Own Brand Labeler(OBL)
Number of Employees	Select 1-5 5-10 10-25 15-25 25-50 50-100 100-200 200-400
Scope of CERT3GLOBAL	Select Guidance, Documentation and Internal Audit Support Guidance, Documentation and Internal Audit and External Audit Support
Documentation experience and Device Knowledge of the person coordinate with Consultants	Select Good Average Poor
3. MEDICAL DEVICE DESCRIPTION
Type of Device	Select Standalone Software Active Device Non Active Device Procedural Pack (Kits) Reusable Surgical Instruments Medicinal Device Measuring Device Animal Origin Device
Scope
Device Body Contact	Select Not Applicable External Body Contact Non Body Contact Less than 1 minute Less than 2 minutes Less than 5 minutes Less than 60 minutes Less than 30 days. More than 30 days.
Medical device used at	Select OEM Home use Clinical Use Home and Clinical Use Combination with other medical device
Medical Device packed	Select Sterile Non Sterile
4. SUBMITTER INFORMATION
Contact Person* Select Mr Mrs Dr Prof Ms
Job Title*
Contact Number*
Contact Email*