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Executive Certificate in Medical Device Quality Control

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Medical Device Quality Control: This Executive Certificate equips professionals with essential knowledge and practical skills in medical device regulations. Designed for quality engineers, regulatory affairs professionals, and management, the program covers GMP, risk management, and quality system regulations (QSR).

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์ด ๊ณผ์ •์— ๋Œ€ํ•ด

Learn to implement effective quality assurance processes, conduct audits, and ensure compliance with global standards like ISO 13485. Boost your career in the medical device industry. Gain the competitive edge you need to excel. Explore the program details and register today! Advance your expertise and impact patient safety.

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๋Œ€๊ธฐ ๊ธฐ๊ฐ„ ์—†์Œ

๊ณผ์ • ์„ธ๋ถ€์‚ฌํ•ญ

  • Introduction to Medical Device Regulations and Standards
  • Quality Management Systems (QMS) for Medical Devices
  • Design Control and Risk Management
  • Good Manufacturing Practices (GMP) for Medical Devices
  • Quality Auditing and Internal Controls
  • CAPA (Corrective and Preventive Actions)
  • Medical Device Reporting (MDR) and Post-Market Surveillance
  • Statistical Process Control (SPC) in Medical Device Manufacturing

๊ฒฝ๋ ฅ ๊ฒฝ๋กœ

Career Role Description Quality Control Specialist (Medical Devices) Ensures compliance with regulatory standards (e.g., ISO 13485) for medical devices.

Involves testing, documentation, and process improvement within Quality Management Systems.

Regulatory Affairs Specialist (Medical Devices) Manages regulatory submissions and compliance for medical devices throughout the product lifecycle.

Key skills include knowledge of MDR/IVDR and interactions with regulatory bodies.

Quality Engineer (Medical Devices) Focuses on implementing and improving quality systems, performing root cause analysis and audits, and driving continuous improvement initiatives within medical device manufacturing.

Medical Device Auditor Conducts internal and external audits of medical device facilities, ensuring compliance with regulatory requirements and quality standards.

Experience with GMP is highly valued.

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์ด ๊ณผ์ •์˜ ๋น„์šฉ์„ ์ง€๋ถˆํ•˜๊ธฐ ์œ„ํ•ด ํšŒ์‚ฌ๋ฅผ ์œ„ํ•œ ์ฒญ๊ตฌ์„œ๋ฅผ ์š”์ฒญํ•˜์„ธ์š”.

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์ƒ˜ํ”Œ ์ธ์ฆ์„œ ๋ฐฐ๊ฒฝ
EXECUTIVE CERTIFICATE IN MEDICAL DEVICE QUALITY CONTROL
์—๊ฒŒ ์ˆ˜์—ฌ๋จ
ํ•™์Šต์ž ์ด๋ฆ„
์—์„œ ํ”„๋กœ๊ทธ๋žจ์„ ์™„๋ฃŒํ•œ ์‚ฌ๋žŒ
London School of International Business (LSIB)
์ˆ˜์—ฌ์ผ
05 May 2025
๋ธ”๋ก์ฒด์ธ ID: s-1-a-2-m-3-p-4-l-5-e
์ด ์ž๊ฒฉ์ฆ์„ LinkedIn ํ”„๋กœํ•„, ์ด๋ ฅ์„œ ๋˜๋Š” CV์— ์ถ”๊ฐ€ํ•˜์„ธ์š”. ์†Œ์…œ ๋ฏธ๋””์–ด์™€ ์„ฑ๊ณผ ํ‰๊ฐ€์—์„œ ๊ณต์œ ํ•˜์„ธ์š”.
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