Medical Device Testing

It is a regulatory requirement ensuring that the device is compatible with the biological system where it will use.

Medical device testing is crucial for CE certification because it verifies that the device performs safely and effectively as intended. Testing provides evidence that the device meets the required standards and regulatory requirements under the EU Medical Device Regulation (MDR). It helps identify any defects or risks, ensuring only safe, reliable, and compliant devices reach patients. Accredited labs conduct these tests following strict protocols, and their reports are essential for demonstrating conformity to notified bodies, which is mandatory for obtaining the CE mark. Without proper testing, the certification process cannot confirm that the device is suitable for market release.

Type testing in medical devices refers to a series of standardised tests performed on a specific model or design of a medical device to verify that it meets required safety, performance, and regulatory standards. It ensures that the device consistently performs as intended and is safe for use before it is released to the market or used on patients. These tests assess various aspects such as functionality, biocompatibility, chemical safety, and durability, based on the device’s material, manufacturing process, and applicable regulations. Type testing is conducted by accredited laboratories following approved protocols, and provides documented evidence of the device’s compliance with global standards.

Maven offers guidance throughout the medical device testing process. We help identify the specific testing requirements based on your device’s material, manufacturing process, and applicable standards and regulations. We advise on the appropriate tests needed, such as performance testing, biocompatibility, clinical and pre-clinical testing, chemical analysis, and quality assurance checks.

Additionally, we assist in coordinating with accredited testing laboratories that comply with international standards like ISO 17025 and GLP certification. We ensure that the labs follow approved testing protocols and provide compliant test reports.

With our expertise, we interpret test standards and guidelines, define suitable test methods, parameters, and acceptance criteria tailored to your device.