Medical Device Quality Requirements Course
Gstudy > Courses and seminars > Medical Device Quality Requirements Course
Quality
Location: Frontal
Starts at: 09:30
Duration: 2 מפגשים
Language: עברית
This course provides a comprehensive understanding of ISO 13485:2016 and 21 CFR 820 standards, focusing on building a quality culture and implementing Quality Management Systems (QMS). Key topics include:
- Document and record control (QMS, DHF, DMR, DHR)
- Design and production controls
- Resource management
- Purchasing controls and supplier evaluation
- Statistical acceptance sampling principles
- Problem-solving using advanced tools like SPC and CAPA
About Dana Tirosh B.A.
Regulatory and Quality expert and a certified lead auditor (BSI Certified Lead Auditor - ISO 13485:2016 IRCA Certified) Experienced in establishing, implementing and maintaining a QMS, well familiar with international standards and regulations, audit management, project oversight and Global Regulatory Submissions. Successfully participated in many ISO 13485, EU and MDSAP Audits as the lead point of contact. Dana is...
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Comments
בקורס ילמדו היסודות של בניית תרבות לאיכות ובניית מערכת איכות לפי ISO13485:2016 ו-21CFR820, כולל בקרת מסמכים ורשומות (רשומות QMS,DHR,DMR, DHF), אחריות הנהלה, ניהול משאבים, סקרי איכות, בקרות
רכש , הערכה ובחירת ספקים, עקרונות בדיקת דגימת קבלה, בקרת תכן, בקרת ייצור ושירות ובקרת ציוד מדידה. כולל עקרונות לבחירת דגימה סטטיסטית.