Medical Devices Testing
Following the Medical device regulation EU 2017/745, Medical Devices Testing is a critical step to ensure their safety, efficacy, and regulatory compliance before they can be placed on the market. A comprehensive testing approach is essential to mitigate potential biological and chemical risks associated with the device and its materials. Key elements of this evaluation include biological evaluation planning, biocompatibility testing, chemical characterization, and toxicological risk assessment. Together, these studies provide a robust framework for identifying potential hazards, assessing risk levels, and demonstrating that the medical device is safe for its intended use.
Proper medical device testing not only safeguards patient health but also supports manufacturers in meeting regulatory expectations, avoiding costly recalls, and minimizing delays in product launch. Each stage of testing allows developers to verify device performance, optimize materials and design, and substantiate safety claims with scientifically validated evidence.
Why QACS, The Challenge Test Lab
At QACS we offer GLP compliant, ISO 9001 and ISO 17025 accredited laboratory testing services specifically designed to support compliance with Medical Device Regulation requirements. By partnering with us, clients gain access to expertise and resources that help them:
- Evaluate medical devices and their components for biological and chemical safety
- Minimize cost and time during product design, development, and market launch
- Ensure regulatory compliance throughout the product lifecycle
- Deliver safe, efficient, and effective products to end users
For Medical Devices Testing contact us – [email protected] – +30 210 29 34745