| Aspect | Medical Device Quality Control | Medical Device Quality Assurance |
|---|
| Focus | Inspecting and testing products to identify defects | Developing and maintaining quality systems and processes |
| Activities | Product testing, inspection, sampling | Audits, process validation, compliance management |
| Certifications | ISO 13485, GMP training | ISO 13485, regulatory standards |
| Work Environment | Laboratories, manufacturing floors | Quality departments, regulatory offices |
Medical Device Quality Control focuses on testing and inspecting products to ensure they meet quality standards, while Medical Device Quality Assurance emphasizes establishing systems and processes to prevent defects and ensure compliance. Both roles are essential in maintaining high-quality medical devices and often work closely within the industry.