South East Technological University
South East Technological University

Master of Science in Medical Device Regulatory Affairs

South East Technological University, Ireland

Course Overview

Dive into the intricacies of regulatory affairs with our specialized program, offering a comprehensive perspective on the regulatory landscape. Our program goes beyond conventional boundaries, offering an in-depth exploration of current and anticipated EU legislation. Geared towards medical device regulatory affairs, this initiative equips students with advanced theoretical knowledge crucial for navigating the complex processes and practices inherent to the field. Elevate your understanding of regulatory affairs and position yourself at the forefront of compliance in the ever-evolving landscape.

Course Type
PG
Course Nature
Full Time
Course Duration
1 Year
Total Fee
€14000
Intake
September 2024
Language Proficiency

Under Graduation: 60%  

IELTS: 6.5

Duolingo : 110

Documents Required
  • 10TH
  • 12TH
  • DEGREE
  • DEGREE PROVISSIONAL CERTIFICATE
  • Degree Consolidated Marksheet
  • Degree Individual Marksheet
  • PASSPORT
  • LOR 1
  • LOR 2
  • CV
  • IELTS
  • SOP
  • EXPERIANCE CERTIFICATES
University
South East Technological University
University Details

Syllabus

Course Description: This program is designed to provide students with in-depth knowledge and skills in regulatory affairs specifically tailored for the medical device industry. It covers a range of topics including regulatory frameworks, quality management systems, clinical trial regulations, and the submission processes for gaining approval from regulatory authorities.


Module 1: Introduction to Medical Device Regulatory Affairs

  • Overview of Medical Device Industry
  • Regulatory Agencies and Frameworks
  • Global Harmonization and Regulatory Compliance

Module 2: Regulatory Strategies and Planning

  • Developing Regulatory Strategies
  • Regulatory Planning for Different Markets
  • Risk Management in Regulatory Affairs

Module 3: Quality Management Systems for Medical Devices

  • ISO 13485:2016 and Quality Management Systems
  • Good Manufacturing Practice (GMP) for Medical Devices
  • Auditing and Certification Processes

Module 4: Pre-Clinical and Clinical Trial Regulations

  • Ethical Considerations in Clinical Trials
  • Designing and Conducting Pre-Clinical Studies
  • Regulatory Requirements for Clinical Trials

Module 5: Medical Device Design and Development

  • Design Control in Regulatory Context
  • Human Factors Engineering in Medical Devices
  • Post-Market Surveillance and Vigilance

Module 6: Regulatory Submissions and Approvals

  • Preparing Regulatory Submissions
  • Interaction with Regulatory Authorities
  • Post-Approval Requirements and Reporting

Module 7: Global Regulatory Perspectives

  • Regulatory Environment in Key Regions (e.g., FDA in the U.S., EU Medical Device Regulation)
  • Managing Global Regulatory Challenges
  • Case Studies of Successful Regulatory Approvals

Module 8: Emerging Trends in Medical Device Regulatory Affairs

  • Digital Health and Regulatory Considerations
  • Personalized Medicine and Regulatory Challenges
  • Future Directions in Regulatory Affairs

Module 9: Regulatory Compliance and Enforcement

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