Certified Specialist Programme in Medical Device Regulation
-- viewing nowMedical 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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Course details
• 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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