Certificate in IVD Regulatory Affairs Compliance Strategies
-- ViewingNowThe Certificate in IVD Regulatory Affairs Compliance Strategies course is a comprehensive program designed to equip learners with the essential skills needed to navigate the complex world of in vitro diagnostic (IVD) regulatory affairs. This course is vital for professionals working in or seeking to enter the IVD industry, where regulatory compliance is paramount.
5,744+
Students enrolled
GBP £ 149
GBP £ 215
Save 44% with our special offer
ě´ ęłźě ě ëí´
100% ě¨ëźě¸
ě´ëěë íěľ
ęłľě ę°ëĽí ě¸ěŚě
LinkedIn íëĄíě ěśę°
ěëŁęšě§ 2ę°ě
죟 2-3ěę°
ě¸ě ë ěě
ë기 ę¸°ę° ěě
ęłźě ě¸ëśěŹí
⢠IVD Regulations Overview
⢠Understanding IVD Directive 98/79/EC
⢠Essentials of ISO 13485 Quality Management System
⢠IVD Classification and Risk Assessment
⢠IVD Technical File Preparation
⢠Understanding IVD Notified Bodies and Conformity Assessment Procedures
⢠Post-Market Surveillance and Vigilance in IVDs
⢠EU MDR and IVDR Transition Strategy
⢠IVD Labeling, Instructions for Use, and Packaging Requirements
⢠Global IVD Regulatory Harmonization and International Standards
ę˛˝ë Ľ 경ëĄ
ě í ěęą´
- 죟ě ě ëí 기본 ě´í´
- ěě´ ě¸ě´ ëĽěë
- ěť´í¨í° ë° ě¸í°ëˇ ě ꡟ
- 기본 ěť´í¨í° 기ě
- ęłźě ěëŁě ëí íě
ěŹě ęłľě ěę˛Šě´ íěíě§ ěěľëë¤. ě ꡟěąě ěí´ ě¤ęłë ęłźě .
ęłźě ěí
ě´ ęłźě ě ę˛˝ë Ľ ę°ë°ě ěí ě¤ěŠě ě¸ ě§ěęłź 기ě ě ě ęłľíŠëë¤. ꡸ę˛ě:
- ě¸ě ë°ě 기ę´ě ěí´ ě¸ěŚëě§ ěě
- ęśíě´ ěë 기ę´ě ěí´ ęˇě ëě§ ěě
- ęłľě ě겊ě ëł´ěě
ęłźě ě ěąęłľě ěźëĄ ěëŁí늴 ěëŁ ě¸ěŚě뼟 ë°ę˛ ëŠëë¤.
ě ěŹëë¤ě´ ę˛˝ë Ľě ěí´ ě°ëŚŹëĽź ě ííëę°
댏롰 ëĄëŠ ě¤...
ě죟 돝ë ě§ëʏ
ě˝ě¤ ěę°ëŁ
- 죟 3-4ěę°
- 쥰기 ě¸ěŚě ë°°ěĄ
- ę°ë°Ší ëąëĄ - ě¸ě ë ě§ ěě
- 죟 2-3ěę°
- ě 기 ě¸ěŚě ë°°ěĄ
- ę°ë°Ší ëąëĄ - ě¸ě ë ě§ ěě
- ě 체 ě˝ě¤ ě ꡟ
- ëě§í¸ ě¸ěŚě
- ě˝ě¤ ěëŁ
ęłźě ě ëł´ ë°ę¸°
íěŹëĄ ě§ëś
ě´ ęłźě ě ëšěŠě ě§ëśí기 ěí´ íěŹëĽź ěí ě˛ęľŹě뼟 ěě˛íě¸ě.
ě˛ęľŹěëĄ ę˛°ě ę˛˝ë Ľ ě¸ěŚě íë