Global Certificate Course in Medical Device Compliance Regulations
-- viewing nowMedical Device Compliance Regulations: Gain a global perspective on medical device regulations. This intensive course is for regulatory affairs professionals, quality engineers, and medical device manufacturers needing comprehensive knowledge of international standards.
6,373+
Students enrolled
GBP £ 140
GBP £ 202
Save 44% with our special offer
About this course
100% online
Learn from anywhere
Shareable certificate
Add to your LinkedIn profile
2 months to complete
at 2-3 hours a week
Start anytime
No waiting period
Course details
• Quality System Regulations (QSR) and ISO 13485:2016
• Risk Management in Medical Device Development
• Design Controls and Verification & Validation
• Regulatory Submissions and Post-Market Surveillance
• Clinical Evaluation and Data Management
• Labeling and Packaging Requirements
• Global Harmonization and International Regulations (e.g., MDD, MDR, FDA)
Career path
Career Role | Description |
---|---|
Regulatory Affairs Specialist (Medical Devices) | Ensure compliance with UK and EU Medical Device Regulations (MDR/IVDR). A crucial role for product lifecycle management. |
Quality Assurance Engineer (Medical Devices) | Oversee quality systems and processes, guaranteeing product safety and regulatory compliance. High demand in the UK's thriving medical device sector. |
Clinical Affairs Specialist (Medical Devices) | Bridge the gap between clinical research and regulatory requirements. Essential for clinical evidence generation and regulatory submissions. |
Medical Device Compliance Consultant | Provide expert guidance on regulatory strategies and compliance solutions. High earning potential for experienced professionals. |
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.
Why people choose us for their career
Loading reviews...
Frequently Asked Questions
Course fee
- 3-4 hours per week
- Early certificate delivery
- Open enrollment - start anytime
- 2-3 hours per week
- Regular certificate delivery
- Open enrollment - start anytime
- Full course access
- Digital certificate
- Course materials
Get course information
Earn a career certificate
