Global Certificate Course in Medical Device Regulation

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Medical Device Regulation: Navigate the complex landscape of global medical device regulations. This intensive course is designed for medical device professionals, including engineers, manufacturers, and regulatory affairs specialists.

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About this course

Learn about FDA regulations, EU MDR, and other key international standards. Gain practical knowledge of quality management systems (QMS), risk management, and clinical evaluation. Improve compliance and reduce market entry challenges. Master regulatory submissions and post-market surveillance. Boost your career prospects in this rapidly evolving industry. Enroll today and become a leading expert in global medical device regulations. Explore the course details now!

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Course details

• Introduction to Medical Device Regulations & Classification
• Regulatory Pathways & Submissions (e.g., 510(k), PMA)
• Quality System Regulations (QSR) and ISO 13485
• Risk Management & Clinical Evaluation
• Design Controls & Verification/Validation
• Post-Market Surveillance & Vigilance
• Global Harmonization & International Standards (e.g., ISO 14971, IEC 60601)
• Regulatory Affairs Strategy & Compliance
• Medical Device Law & Liability

Career path

Global Certificate in Medical Device Regulation: UK Career Outlook

Career Role Description
Regulatory Affairs Specialist (Medical Devices) Ensure compliance with UK and EU medical device regulations (MDR, IVDR). High demand for professionals with strong knowledge of regulatory pathways and submissions.
Quality Assurance Manager (Medical Devices) Oversee quality systems and compliance within medical device companies. Requires strong understanding of ISO 13485 and other quality standards.
Clinical Affairs Specialist Manage clinical data and evidence generation, crucial for regulatory approvals and post-market surveillance. Experience in clinical trials highly valued.
Medical Device Consultant Provide expert advice on regulatory strategies and compliance to manufacturers. Deep understanding of regulatory landscape and extensive experience needed.

Entry requirements

  • Basic understanding of the subject matter
  • Proficiency in English language
  • Computer and internet access
  • Basic computer skills
  • Dedication to complete the course

No prior formal qualifications required. Course designed for accessibility.

Course status

This course provides practical knowledge and skills for professional development. It is:

  • Not accredited by a recognized body
  • Not regulated by an authorized institution
  • Complementary to formal qualifications

You'll receive a certificate of completion upon successfully finishing the course.

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GLOBAL CERTIFICATE COURSE IN MEDICAL DEVICE REGULATION
is awarded to
Learner Name
who has completed a programme at
London School of International Business
Awarded on
05 May 2025
Blockchain Id: s-1-a-2-m-3-p-4-l-5-e
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