Certified Specialist Programme in Medical Device Validation Testing

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Medical Device Validation Testing certification equips professionals with in-depth knowledge of regulatory requirements (e.g.

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, ISO 13485, 21 CFR Part 820). This Certified Specialist Programme is designed for quality engineers, validation engineers, and regulatory affairs professionals involved in medical device manufacturing. The curriculum covers risk management, design verification, and design validation testing methodologies. Software validation and performance testing are also key components. Gain a competitive edge and ensure product safety and regulatory compliance. Enroll now and advance your career in medical device validation!

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๊ณผ์ • ์„ธ๋ถ€์‚ฌํ•ญ

  • Medical Device Regulations and Standards
  • Risk Management and Hazard Analysis
  • Design Verification and Validation
  • Software Validation and Testing
  • Electrical Safety Testing
  • Biocompatibility Testing
  • Sterility and Sterilization Validation
  • Performance Testing and Verification
  • Good Documentation Practices (GDP) in Validation
  • Auditing and CAPA in Medical Device Validation

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Career Role Description Medical Device Validation Engineer Develops and executes validation plans for medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485).

High demand for strong problem-solving and technical skills.

Quality Assurance Specialist (Medical Devices) Oversees quality control processes throughout the medical device lifecycle.

Requires expertise in regulatory affairs and quality management systems.

Crucial for validation testing .

Test Engineer (Medical Devices) Designs and conducts performance testing, ensuring the reliability and safety of medical devices.

Focuses on validation and verification activities.

Regulatory Affairs Specialist (Medical Devices) Navigates regulatory requirements for medical device submissions.

Plays a vital role in ensuring successful product validation and market launch.

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์ƒ˜ํ”Œ ์ธ์ฆ์„œ ๋ฐฐ๊ฒฝ
CERTIFIED SPECIALIST PROGRAMME IN MEDICAL DEVICE VALIDATION TESTING
์—๊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
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