Certificate in Medical Device Safety Regulations
-- ViewingNowThe Certificate in Medical Device Safety Regulations is a crucial course for professionals seeking expertise in the medical device industry. This program highlights the importance of regulatory compliance, ensuring the safety and effectiveness of medical devices, and minimizing risks for patients and healthcare providers.
2,606+
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
⢠Introduction to Medical Device Safety Regulations: Overview of global medical device safety regulations, regulatory bodies, and their roles
⢠Regulatory Pathways for Medical Devices: Analyzing different regulatory pathways for medical devices including premarket approval (PMA), 510(k) Premarket Notification, and EU Medical Device Regulation (MDR)
⢠Quality System Requirements: Understanding quality system standards, such as ISO 13485, and their significance in medical device safety
⢠Risk Management in Medical Devices: Applying risk management principles, such as ISO 14971, and conducting risk assessments
⢠Medical Device Labeling and Instructions for Use: Designing clear, accurate, and compliant labeling and IFU for medical devices
⢠Medical Device Clinical Trials and Post-Market Surveillance: Managing clinical trials, post-market surveillance, and vigilance reporting
⢠Medical Device Cybersecurity: Implementing cybersecurity best practices and understanding FDA guidance on cybersecurity for medical devices
⢠Inspection Preparedness and Compliance: Preparing for regulatory inspections and ensuring continuous compliance
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§ëŹ¸
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
