Certified Specialist Programme in Medical Device Regulation

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Medical Device Regulation specialists are in high demand. Our Certified Specialist Programme provides in-depth knowledge of EU MDR, FDA regulations, and global compliance.

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About this course

It's designed for quality assurance professionals, regulatory affairs specialists, and anyone involved in medical device lifecycle management. Learn about risk management, clinical evaluation, and post-market surveillance. Gain practical skills and expert insights to navigate the complex regulatory landscape. Enhance your career prospects and contribute to patient safety. This intensive programme ensures you're equipped to meet the challenges of medical device certification. Register today and elevate your expertise in medical device regulation. Explore the programme details now!

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Course details

• Introduction to Medical Device Regulations
• Classification of Medical Devices
• Regulatory Pathways and Approvals
• Quality Management Systems (ISO 13485)
• Technical Documentation and File Requirements
• Post-Market Surveillance and Vigilance
• Clinical Evaluation and Data Requirements
• EU MDR and US FDA Regulations
• International Harmonization and Global Regulations
• Regulatory Affairs Strategy and Compliance

Career path

Career Role (Medical Device Regulation) Description
Regulatory Affairs Specialist Ensuring medical device compliance with UK and EU regulations. Key responsibilities include submissions, registrations, and vigilance.
Quality Assurance Manager (Medical Devices) Overseeing quality management systems for medical devices, ensuring adherence to regulatory standards, and conducting audits. A crucial role in ensuring patient safety and product quality.
Clinical Affairs Specialist Focuses on clinical evaluation, post-market surveillance, and managing clinical data related to medical devices, ensuring safety and effectiveness claims.

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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Sample Certificate Background
CERTIFIED SPECIALIST PROGRAMME 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
Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.
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