Global Certificate Course in Medical Device Compliance Regulations

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Medical Device Compliance Regulations: Gain a global perspective on medical device regulations. This intensive course is for regulatory affairs professionals, quality engineers, and medical device manufacturers needing comprehensive knowledge of international standards.

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About this course

Learn about ISO 13485, EU MDR, and FDA 21 CFR Part 820. Understand quality management systems, risk management, and post-market surveillance. Master compliance strategies and avoid costly mistakes. Global certification enhances your career prospects and strengthens your company's reputation. Enroll now and elevate your expertise in medical device compliance. Explore the full curriculum and register today!

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Course details

• Introduction to Medical Device Regulations & Classifications
• Quality System Regulations (QSR) and ISO 13485:2016
• Risk Management in Medical Device Development
• Design Controls and Verification & Validation
• Regulatory Submissions and Post-Market Surveillance
• Clinical Evaluation and Data Management
• Labeling and Packaging Requirements
• Global Harmonization and International Regulations (e.g., MDD, MDR, FDA)

Career path

Career Role Description
Regulatory Affairs Specialist (Medical Devices) Ensure compliance with UK and EU Medical Device Regulations (MDR/IVDR). A crucial role for product lifecycle management.
Quality Assurance Engineer (Medical Devices) Oversee quality systems and processes, guaranteeing product safety and regulatory compliance. High demand in the UK's thriving medical device sector.
Clinical Affairs Specialist (Medical Devices) Bridge the gap between clinical research and regulatory requirements. Essential for clinical evidence generation and regulatory submissions.
Medical Device Compliance Consultant Provide expert guidance on regulatory strategies and compliance solutions. High earning potential for experienced professionals.

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 COMPLIANCE REGULATIONS
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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