Masterclass Certificate in Medical Device Quality Assurance
-- viewing nowThe Masterclass Certificate in Medical Device Quality Assurance is a comprehensive course that provides learners with critical skills for success in the medical device industry. This program focuses on the importance of quality assurance in medical devices, addressing industry demand for professionals who can ensure compliance with regulatory standards and maintain high-quality products.
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Course details
• Risk Management in Medical Device Development
• Design Controls for Medical Devices
• Good Manufacturing Practices (GMP) for Medical Devices
• Medical Device Regulations (e.g., FDA 21 CFR Part 820, EU MDR)
• Auditing and Inspection Procedures
• Corrective and Preventive Actions (CAPA)
• Postmarket Surveillance and Vigilance
• Supplier Management and Quality Agreements
• Quality System Documentation and Record Keeping
Career path
Career Role | Description |
---|---|
Medical Device Quality Assurance Specialist (UK) | Ensuring compliance with regulations like MDR and IVDR. Focus on quality systems, audits, and CAPA management within the UK medical device market. High demand for problem-solving skills and regulatory knowledge. |
Regulatory Affairs Manager (Medical Devices) | Navigating the complex regulatory landscape of UK medical device approvals. Managing submissions and maintaining compliance with evolving standards. Expertise in regulatory affairs is critical. |
Quality Engineer, Medical Devices | Implementing quality control procedures throughout the medical device lifecycle. Focus on design control, process validation, and continuous improvement initiatives. Strong engineering and problem-solving abilities are key. |
Senior Quality Assurance Auditor (Medical Devices) | Conducting internal and external audits to verify quality system effectiveness. Expertise in ISO 13485 and other relevant standards is essential. Significant experience in auditing within the medical device industry is required. |
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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