Certified Specialist Programme in Medical Device Validation Testing
-- viewing nowMedical Device Validation Testing certification equips professionals with in-depth knowledge of regulatory requirements (e.g.
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Course details
• Risk Management and Hazard Analysis
• Design Verification and Validation
• Software Validation and Testing
• Electrical Safety Testing
• Biocompatibility Testing
• Sterility and Sterilization Validation
• Performance Testing and Verification
• Good Documentation Practices (GDP) in Validation
• Auditing and CAPA in Medical Device Validation
Career path
Career Role | Description |
---|---|
Medical Device Validation Engineer | Develops and executes validation plans for medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485). High demand for strong problem-solving and technical skills. |
Quality Assurance Specialist (Medical Devices) | Oversees quality control processes throughout the medical device lifecycle. Requires expertise in regulatory affairs and quality management systems. Crucial for validation testing. |
Test Engineer (Medical Devices) | Designs and conducts performance testing, ensuring the reliability and safety of medical devices. Focuses on validation and verification activities. |
Regulatory Affairs Specialist (Medical Devices) | Navigates regulatory requirements for medical device submissions. Plays a vital role in ensuring successful product validation and market launch. |
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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