의료기기 및 체외진단 의료기기

• Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III
• Technical Documentation
• Clinical Evaluation - MEDDEV 2.7.1 rev.4, MDCG 2020-5
• Product Labeling - ISO 15223-1
• PMS & PSUR, PMCF (+ Vigilance)
• CE QMS 요구사항 업데이트