ISO 13485 Quality Management System

의료기기 산업은 까다로운 품질 시스템과 제품 요구사항을 충족해야 하는, 가장 강력한 규제 대상 분야 중 하나입니다. 규제 요구사항은 제조자가 의도한 목적에 적합하고 안전한 의료기기를 일관되게 설계, 생산 및 시장에 배치하도록 하기 위해 존재합니다. ISO 13485 표준은 QMS에 대한 포괄적인 요구사항을 충족시키기 위한 효과적인 솔루션입니다. ISO 13485를 채택함으로써, 제조...

ISO 13485 Training | Internal & Lead Auditor

LRQA provides ISO 13485 training courses including ISO 13485 internal auditor training and ISO 13485 lead auditor training to meet your requirements.

ICR International Certification Registrar

Course Name, AU, TL, Total ; ISO 9001 Lead Auditor Training course, 2days, 1days, 5days ; ISO 14001 Lead Auditor Training course, 2days, 1days, 5days ; ISO 45001 Lead Auditor Training course, 2days, 1days, 5days ; ISO 13485 Lead Auditor Training course, 2days, 1days, 5days

ISO 13485:2016 Medical Device QMS Lead Auditor Training Course (CQI and IRCA Certified) | SGS

This certified course (2428-PR 369) will equip you with the knowledge and skills required to perform audits of MD QMS against ISO 13485:2016, in accordance with ISO 19011 and ISO 17021, as applicable. SGS is a designated UKCA Approved body, a CE Notified Body and a recognized MDSAP Auditing Organization providing accredited training courses and extensive testing capabilities across all Medical Device categories. On completion of this course, you will be able to: In order to adapt to you learning...

ISO 13485

In addition, we offer a range of complementary services: • In Vitro Diagnostic Regulation (IVDR) Technical Documentation Training Course • ISO 13485 Medical Devices QMS Auditor/Lead...

ISO 13485 Certification for Medical Devices & Components

Achieving ISO 13485 certification proves that your medical devices have been manufactured under a certified quality management system. Our auditors have an established history of assessing leading...

2024년 의료기기 교육 과정 소개 [ ISO 13485/ MDR/ MDSAP/ IVDR 이외]

BSI Training Academy 2024년 의료기기 교육 과정 소개 ISO 13485/ MDR/ MDSAP/ IVDR 이외

ISO 13485 Certification Services, Training Courses & Resources

Learn about our ISO 13485 medical device certification services, training courses and resources, covering the 8 quality management principles.

ISO 13485 Auditor Qualifications medical devices quality

auditor qualifications for ISO 13485 – medical devices quality management systems - to give you the skills and knowledge you need to be an auditor practitioner, and by teaching you techniques in pr...

Course guide

ICR ATEX Accredited Testing Lab Product Certification CE NB Medical Device ISO 13485 NRTL Auditor Traning NB 2703 ISO 19443