Global Certificate Course in Medical Device Regulation
-- viewing nowMedical Device Regulation: Navigate the complex landscape of global medical device regulations. This intensive course is designed for medical device professionals, including engineers, manufacturers, and regulatory affairs specialists.
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Course details
• Regulatory Pathways & Submissions (e.g., 510(k), PMA)
• Quality System Regulations (QSR) and ISO 13485
• Risk Management & Clinical Evaluation
• Design Controls & Verification/Validation
• Post-Market Surveillance & Vigilance
• Global Harmonization & International Standards (e.g., ISO 14971, IEC 60601)
• Regulatory Affairs Strategy & Compliance
• Medical Device Law & Liability
Career path
Global 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 (MDR, IVDR). High demand for professionals with strong knowledge of regulatory pathways and submissions. |
Quality Assurance Manager (Medical Devices) | Oversee quality systems and compliance within medical device companies. Requires strong understanding of ISO 13485 and other quality standards. |
Clinical Affairs Specialist | Manage clinical data and evidence generation, crucial for regulatory approvals and post-market surveillance. Experience in clinical trials highly valued. |
Medical Device Consultant | Provide expert advice on regulatory strategies and compliance to manufacturers. Deep understanding of regulatory landscape and extensive experience needed. |
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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