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Graduate Certificate in Medical Device Auditing

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Medical Device Auditing: Gain expertise in regulatory compliance and quality systems. This Graduate Certificate prepares professionals for auditing medical devices.

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์ด ๊ณผ์ •์— ๋Œ€ํ•ด

It covers quality system regulations (e.g., ISO 13485, 21 CFR Part 820). Designed for quality engineers, auditors, and regulatory affairs professionals. Learn best practices for effective audits. Develop skills in documentation review, non-conformance management, and corrective actions. Enhance your career in the medical device industry. Advance your knowledge and become a certified auditor. Explore the program today!

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๊ณผ์ • ์„ธ๋ถ€์‚ฌํ•ญ

  • Medical Device Regulations and Standards
  • Quality System Regulations (QSR) and ISO 13485
  • Auditing Principles and Techniques
  • CAPA (Corrective and Preventive Action) Systems
  • Risk Management in Medical Device Development
  • Good Manufacturing Practices (GMP) for Medical Devices
  • Design Controls and Verification/Validation
  • Medical Device Reporting (MDR) and Postmarket Surveillance
  • Audit Report Writing and Presentation

๊ฒฝ๋ ฅ ๊ฒฝ๋กœ

Career Role Description Medical Device Auditor Conducting audits to ensure compliance with regulations; assessing quality management systems in medical device companies.

High demand due to increasing regulatory scrutiny.

Regulatory Affairs Specialist (Medical Devices) Managing regulatory submissions and compliance; ensuring products meet standards for market access.

Requires deep knowledge of Medical Device regulations and auditing procedures.

Quality Assurance Manager (Medical Devices) Overseeing quality systems and processes; implementing auditing procedures; ensuring product quality and safety.

Strong auditing skills are essential for this role.

Compliance Officer (Medical Devices) Monitoring compliance with regulatory requirements; conducting internal audits; investigating and resolving compliance issues.

Experience with medical device auditing is highly valuable.

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์ƒ˜ํ”Œ ์ธ์ฆ์„œ ๋ฐฐ๊ฒฝ
GRADUATE CERTIFICATE IN MEDICAL DEVICE AUDITING
์—๊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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