Professional Certificate in Advanced Medical Device Testing
-- viewing nowMedical Device Testing: This Professional Certificate equips you with advanced skills in biocompatibility testing, regulatory compliance (FDA, ISO 13485), and performance evaluation. Designed for medical device engineers, quality assurance professionals, and regulatory affairs specialists, this program provides hands-on training in advanced testing methodologies.
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Course details
• Risk Management in Medical Device Testing
• Biocompatibility Testing and Evaluation
• Electrical Safety Testing of Medical Devices
• Mechanical Testing and Performance Evaluation
• Software Validation and Verification for Medical Devices
• Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
• Statistical Analysis and Data Interpretation in Medical Device Testing
• Clinical Trials and Post-Market Surveillance
• Quality System Regulations (QSR) and ISO 13485
Career path
| Career Role (Advanced Medical Device Testing) | Description |
|---|---|
| Senior Medical Device Test Engineer | Leads complex testing projects, ensuring regulatory compliance and high product quality. Extensive experience in medical device testing methodologies. |
| Regulatory Affairs Specialist (Medical Devices) | Manages regulatory submissions and ensures compliance with UK and EU medical device regulations. Deep understanding of medical device testing requirements. |
| Biomedical Engineer (Testing Focus) | Designs and executes tests on biomedical devices, analysing results and contributing to product improvement. Strong background in relevant testing standards. |
| Quality Assurance Specialist (Medical Devices) | Oversees quality control processes throughout the device lifecycle, including rigorous testing procedures. Expertise in quality management systems. |
| Test Automation Engineer (Medical Devices) | Develops and implements automated testing solutions for medical devices, improving efficiency and test coverage. Experience with relevant testing frameworks. |
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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