Masterclass Certificate in Medical Device Regulation

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Medical Device Regulation Masterclass: Gain the expertise needed to navigate the complex world of medical device compliance. This certificate program is designed for regulatory affairs professionals, quality assurance managers, and medical device engineers seeking to enhance their knowledge of FDA regulations, EU MDR, and ISO 13485.

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About this course

Learn about risk management, clinical trials, and post-market surveillance. Master regulatory strategies and compliance procedures. Understand quality system regulations and international standards. Accelerate your career in the medical device industry. Enroll today and unlock your potential.

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Course details

• Introduction to Medical Device Regulations & Classifications
• EU Medical Device Regulation (MDR) 2017/745 & In Vitro Diagnostic Regulation (IVDR) 2017/746
• US Food and Drug Administration (FDA) Regulations for Medical Devices
• Quality Management Systems (QMS) - ISO 13485:2016
• Risk Management & Clinical Evaluation
• Regulatory Strategy & Pathway Selection
• Post-Market Surveillance & Vigilance
• Medical Device Labeling and Packaging Requirements
• Cybersecurity in Medical Devices
• Global Harmonization of Medical Device Regulations

Career path

Masterclass 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. A crucial role in product lifecycle management.
Quality Assurance Manager (Medical Devices) Oversee quality systems and compliance for medical device manufacturing and distribution. High demand for quality professionals.
Clinical Affairs Specialist (Medical Devices) Manage clinical trials and post-market surveillance, ensuring patient safety and regulatory compliance. Strong clinical knowledge is vital.
Medical Device Consultant Provide expert guidance on regulatory strategies and compliance to medical device companies. Requires extensive experience and expertise.

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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MASTERCLASS CERTIFICATE 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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