{"id":4186,"date":"2026-05-24T11:36:28","date_gmt":"2026-05-24T08:36:28","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?post_type=event&p=4186"},"modified":"2026-07-08T19:47:07","modified_gmt":"2026-07-08T16:47:07","slug":"education","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/egitim\/","title":{"rendered":"Educational Services"},"content":{"rendered":"
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\ud83c\udf93 Our Educational Services<\/h4>\n

Practical Training on Medical Device Regulations and Quality Systems<\/h4>\n

For companies operating in the medical device sector, possessing regulatory knowledge is not only a legal requirement but also fundamental to quality, safety, and market access. At Era Management, we empower your teams by offering technical and practical training in MDR, IVDR, ISO standards, and clinical processes.<\/p>\n

Our training programs are tailored specifically to technical experts, quality\/regulation teams, and clinical or R&D departments. They can be offered on-site, online, or in a hybrid format upon request.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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\ud83d\udcd8 Our Training Topics<\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Subject Heading<\/th>\nExplanation<\/th>\n<\/tr>\n
ISO 13485: Quality Management System<\/td>\nStandard structure, application examples, audit preparation.<\/td>\n<\/tr>\n
ISO 14971: Risk Management<\/td>\nRisk analysis, FMEA applications, risk acceptance criteria.<\/td>\n<\/tr>\n
2017\/745 MDR Training<\/td>\nBasic structure, classification, technical file, PMCF processes<\/td>\n<\/tr>\n
2017\/746 IVDR Training<\/td>\nRisk classification and performance data for in-vitro diagnostic devices.<\/td>\n<\/tr>\n
ISO 62366: Usability Engineering<\/td>\nUser interface, usability assessment, test plans<\/td>\n<\/tr>\n
Preparing Technical Documentation<\/td>\nAnnex II & III gereklilikleri, dosya format\u0131 ve i\u00e7erik kontrol\u00fc<\/td>\n<\/tr>\n
GSPR Training (Annex I)<\/td>\nInterpretation of general safety and performance requirements.<\/td>\n<\/tr>\n
Sat\u0131\u015f Sonras\u0131 G\u00f6zetim (PMS & PMCF)<\/td>\nData collection, analysis, and integration with CAPA.<\/td>\n<\/tr>\n
Klinik De\u011ferlendirme & Ara\u015ft\u0131rmalar<\/td>\nCER preparation, ISO 14155, types of work, data sources.<\/td>\n<\/tr>\n
Introduction to Biomechanical Testing<\/td>\nTypes of mechanical tests, planning, test environments, and evaluation.<\/td>\n<\/tr>\n
Internal Audit Training (ISO 13485)<\/td>\nAudit planning, checklists, reporting, and nonconformity management.<\/td>\n<\/tr>\n<\/table>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>
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\ud83c\udfaf E\u011fitim Format\u0131 & Kat\u0131l\u0131mc\u0131lar<\/h3>\n

Our Training Formats<\/h4>\n