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
CERTIFICATES