About Us

Wake Diagnostics Inc – Your Trusted Partner in Medical Device Testing

At Wake Diagnostics, we specialize in providing comprehensive testing and validation services for medical devices, ensuring safety, performance, and regulatory compliance. With state-of-the-art facilities, advanced instrumentation, and a team of experienced scientists and engineers, we help manufacturers bring innovative medical technologies to market with confidence.

Our laboratory operates in accordance with international standards such as ISO/IEC 17025, ISO 10993, and FDA requirements, offering a wide range of services including:

• Biocompatibility testing

• Chemical Characterization testing

• Toxicology Risk Assessments

• Biological Cytotoxicity testing

• Regulatory submission support (FDA, CE, MDR, etc.)

We are committed to quality, integrity, and efficiency, ensuring that every device we test meets the highest standards of patient safety and clinical performance. Whether you’re developing a new product or scaling an existing one, Wake Diagnostics is your partner in achieving market readiness.

Wake Diagnostics– Where Innovation Meets Compliance.

Mission Statement

Our mission is to provide high quality testing and consultative services to help alleviate ailments and monitor health.