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

Mod. O.01.01_ENG

EU Directives and Regulations

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

Annex- Medical Devices Directive

Annex V - Medical Devices Directive

Annex VI - Medical Devices Directive

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