EUROPRISME
Distributor
Cardiology & Cardiovascular
-
ISO 13485 Quality Management System for a Distributor of Implantable Devices Used in Cardiothoracic Surgery
EDUCAT
Manufacturer
Cardiology & Cardiovascular
-
Technical Documentation for CE Marking of a Software Application for Therapeutic Education in Cardiology
BIOTRONIK
Distributor
Cardiology & Cardiovascular
-
Implementation of ISO 9001:2015 and ISO 13485:2016 Quality Management Systems - Monitoring the Quality Management System
BASECAMP Vascular
Manufacturer
Cardiology & Cardiovascular
-
ISO 13485 Quality System Audit
WITH A BRAVE HEART
Distributor
Cardiology & Cardiovascular
-
Implementation of the EN ISO 13485:2016 Quality Management System for a Defibrillator Distributor
SIVIEW
Manufacturer
Ophthalmology & Vision
Audit
Compliance
+1 prestation
-
CE Marking and Implementation of the ISO 13485 Quality Management System
-
Follow-up Audits
LAO
Manufacturer
Ophthalmology & Vision
Compliance
Outsourced Quality Manager
+2 services
-
Implementation of the ISO 13485 Quality Management System and CE Marking
-
Certifications obtained in July 2007
-
HAS Reimbursement Application
CORNELIA Contact
Manufacturer
Ophthalmology & Vision
Compliance
Outsourced Quality Manager
+1 prestation
-
Upgrade to ISO 9001:2000 and ISO 13485 Quality Management Systems
-
Certification through GMED
-
Responsable qualité externalisé
LABORATORY CONTACT SERVICES
Manufacturer
Ophthalmology & Vision
Outsourced Quality Manager
Quality
+1 prestation
-
Monitoring of the ISO 9001 and ISO 13485 Quality Management Systems
-
Regulatory Monitoring of Medical Devices
-
Outsourced Quality Manager Role
BENEDETTI
Manufacturer
Ophthalmology & Vision
-
CE Marking Technical File for a Perforated Eye Patch for Eye Dressings
LUNEAU
Manufacturer
Ophthalmology & Vision
-
Product Upgrade Assessment in Accordance with EN 60601-1 and EN 60601-1-2, 3rd Edition
2M CONTACT
Manufacturer
Ophthalmology & Vision
Compliance
Outsourced Quality Manager
+1 prestation
-
Upgrade of the ISO 9001 Quality Management System
-
CE Marking and ISO 13485 Certification (GMED, February 2003)
-
Responsable qualité externalisé