Medical Device Analysis Service

Biocompatibility Testing/ISO 10993 Series

Comprehensive biocompatibility testing services in accordance with the ISO 10993 series to ensure the safety of medical devices.

Sterility Testing/ISO 11737 Series

Accurate sterility testing as per the ISO 11737 series to guarantee the sterile condition of medical products.

Risk Management Assessment/ISO 14971 Compliance

Risk management assessment in compliance with ISO 14971 to minimize the risks associated with medical devices.

Electrical Safety Testing/IEC 60601 Series

Electrical Safety Testing in compliance with IEC 60601 Series are crucial for ensuring the electromagnetic compatibility and electrical safety of medical devices.

Mechanical Testing

Mechanical testing to assess the durability and performance of medical devices.

Chemical Analysis

Chemical analysis including extractables and leachables testing to ensure the chemical safety of medical devices.

Performance Testing

Performance testing including functional and reliability testing to ensure the optimal performance of medical devices.

Usability Testing

Usability testing based on human factors engineering to enhance the user experience of medical devices.

Clinical Evaluation

Clinical evaluation service, including clinical trials and post-market surveillance to ensure the effectiveness and safety of medical devices.

Shelf Life Testing

Shelf life testing through accelerated aging studies to determine the longevity of medical devices.

Packaging Integrity Testing

Packaging integrity testing including seal strength and barrier testing to ensure the integrity of medical device packaging.

Environmental Testing

Environmental testing such as temperature, humidity, and transport simulations to ensure the stability of medical devices in different environments.

Electromagnetic Compatibility (EMC) Testing/IEC 60601-1-2 Compliance

EMC testing in compliance with IEC 60601-1-2 to ensure the electromagnetic compatibility of medical devices.

Validation of Manufacturing Processes

Validation of manufacturing processes through process validation studies to ensure the quality and consistency of medical device production.

Advanced Analytical Instruments

Professional Technical Team

Customized Service

24/7 Ready