QUOTATION REQUEST Forms

Offer Request for QUALITY SYSTEMS and PRODUCTS

Mequipe Assignment Form (for Notified Body)

INSPECTIONS Offer Request

TRAINING Offer Request

(EU) AUTHORISED REPRESENTATIVE Offer Request

EU Directives and Regulations

183.00.06 - General conditions– LAB - Rev.1 del 12.10.20

Low Voltage Directive - EN

Low Voltage Directive - IT

Electromagnetic Compatibility Directive - IT

Electromagnetic Compatibility Directive - EN

Medical Devices Directive

Regulation (EU) 2017-745 - IT

Regulation (EU) 2017-745 - EN

Clinical Tests Forms

01 - Manufacturer's Declaration

02 - Manufacturer Affidavit

03 - Clinical Test Notification

04 - Clinical Test Notification- Summary Model

05 - Proxy

Complaints

Mod. - Complaint