Certified Specialist Programme in Biomedical Device Regulation

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Biomedical Device Regulation: This Certified Specialist Programme equips professionals with in-depth knowledge of global regulatory requirements. Designed for regulatory affairs professionals, quality engineers, and medical device manufacturers, this programme covers FDA, EU MDR, and ISO 13485 standards.

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Gain practical skills in compliance, risk management, and quality systems. Master regulatory submissions and navigate complex approval processes. Enhance your career prospects and contribute to safer medical devices. Learn more and register today to secure your place!

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๊ณผ์ • ์„ธ๋ถ€์‚ฌํ•ญ

  • Introduction to Biomedical Device Regulation
  • Regulatory Pathways and Classifications
  • Quality System Regulations (QSR) and ISO 13485
  • Risk Management for Medical Devices
  • Design Controls and Verification & Validation
  • Clinical Evaluation and Post-Market Surveillance
  • Regulatory Affairs and Submissions
  • International Medical Device Regulations
  • Regulatory Compliance and Auditing
  • Emerging Technologies and Regulatory Challenges

๊ฒฝ๋ ฅ ๊ฒฝ๋กœ

Career Role in Biomedical Device Regulation (UK) Description Regulatory Affairs Specialist Ensuring compliance with UK and EU medical device regulations (MDR, IVDR).

Manages registrations, submissions, and post-market surveillance activities for biomedical devices.

High demand for expertise in quality systems and risk management.

Quality Assurance Manager (Biomedical Devices) Oversees quality management systems (QMS) for biomedical device manufacturers.

Conducts audits, manages CAPAs, and ensures compliance with ISO 13485 and other relevant standards.

Crucial for maintaining product safety and regulatory compliance.

Clinical Affairs Specialist (Biomedical Devices) Supports the clinical evaluation process for medical devices, contributing to clinical investigations and post-market surveillance.

A key role in demonstrating the safety and efficacy of devices for regulatory submissions.

Requires strong scientific background.

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์ƒ˜ํ”Œ ์ธ์ฆ์„œ ๋ฐฐ๊ฒฝ
CERTIFIED SPECIALIST PROGRAMME IN BIOMEDICAL DEVICE REGULATION
์—๊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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