Certified Professional in Medical Device Validation
-- viewing nowCertified Professional in Medical Device Validation (CPMDV) is a crucial certification for professionals in the medical device industry. It validates expertise in design verification and validation processes.
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Course details
• Risk Management (ISO 14971)
• Design Control
• Software Validation (including GAMP)
• Verification and Validation (V&V) methodologies
• Process Validation
• Cleaning and Sterilization Validation
• Regulatory Affairs (FDA, EU MDR)
• Auditing and CAPA (Corrective and Preventive Actions)
Career path
Certified Professional in Medical Device Validation: Career Roles in the UK | Description |
---|---|
Validation Engineer (Medical Devices) | Leads the validation process for medical devices, ensuring compliance with regulatory standards. Focuses on design validation, process validation, and software validation. High demand. |
Quality Assurance Specialist (Medical Devices) | Ensures quality control and compliance throughout the medical device lifecycle, collaborating closely with Validation Engineers. Strong emphasis on GMP and regulatory affairs. |
Regulatory Affairs Specialist (Medical Devices) | Navigates complex regulatory landscapes, ensuring compliance for medical device submissions and approvals in the UK and EU. Deep understanding of MDR and IVDR regulations. |
Senior Validation Engineer (Medical Devices) | Leads and mentors a team of Validation Engineers, providing technical guidance and strategic direction for validation projects. Significant experience and expertise required. |
Compliance Manager (Medical Devices) | Oversees the overall compliance strategy for medical device manufacturing and distribution, including validation activities. Responsible for audits and regulatory inspections. |
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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