• Certificate Number: FR097604
• Client Name: EMKA ELECTRONIQUE
• Accreditation Body: COFRAC
• Standard: ISO 13485:2016
• Scope: SOUS-TRAITANCE POUR LES DISPOSITIFS MEDICAUX NON INVASIFS, NON IMPLANTABLES ET NON STERILES : CONCEPTION, DEVELOPPEMENT, INDUSTRIALISATION, FABRICATION ET INTEGRATION DE PRODUITS ELECTRONIQUES, ELECTROTECHNIQUES. PRESTATION DE SOUTIEN APRES VENTE (REPARATION, MISE A NIVEAU). SUBCONTRACTING FOR NON-INVASIVE, NON-IMPLANTABLE AND NON-STERILE MEDICAL DEVICES: DESIGN, DEVELOPMENT, INDUSTRIALIZATION, MANUFACTURING AND INTEGRATION OF ELECTRONIC, ELECTROTECHNICAL SYSTEMS. AFTER SALES SUPPORT PROVISION (REPAIR, UPGRADE).
• Validity date: 2028-07-17