Advanced Certificate in Medical Device Compliance
-- viewing nowMedical Device Compliance: This advanced certificate equips professionals with in-depth knowledge of regulatory requirements. Learn to navigate complex quality systems and risk management for medical devices.
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Course details
• Quality Management Systems (ISO 13485)
• Risk Management (ISO 14971)
• Design Controls
• Clinical Evaluation
• Post-Market Surveillance
• Labeling and Packaging
• Auditing and Inspections
• Good Manufacturing Practices (GMP)
• International Regulations (e.g., FDA, MDR, etc.)
Career path
Career Role (Medical Device Compliance) | Description |
---|---|
Regulatory Affairs Specialist | Ensuring medical device compliance with UK and EU regulations, including submissions and documentation. |
Quality Assurance Manager | Overseeing quality management systems for medical devices, guaranteeing product safety and regulatory compliance. |
Compliance Auditor | Conducting audits of medical device manufacturers, suppliers and distributors to maintain compliance. |
Clinical Affairs Specialist | Managing clinical evaluations and post-market surveillance, ensuring ongoing safety and efficacy. |
Medical Device Consultant | Providing expert advice on all aspects of medical device compliance, from strategy to implementation. |
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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