Medical Device Safety Testing

Medical Device Safety Testing

The safety and effectiveness of medical devices are of paramount importance in the healthcare industry. Before these devices are approved for use, they must undergo rigorous testing to ensure that they meet the necessary safety standards. Protheragen-ING Lab specializes in providing comprehensive and reliable medical device safety testing services. Our state-of-the-art facilities, experienced team of experts, and commitment to quality make us a trusted partner in ensuring the safety and efficacy of medical devices. With a focus on adherence to regulatory standards and industry best practices, we offer a wide range of testing services to meet the unique needs of our clients.

Fig.1 Medical Device Safety Testing

Comprehensive safety testing solutions

Protheragen-ING Lab's safety testing for medical devices covers a wide range of assessments. These tests are effective in reducing risk, preventing adverse events, and safeguarding patient health and well-being.

Endotoxins, also known as pyrogens, are toxins found in the cell walls of certain bacteria. These substances can cause serious adverse reactions such as fever and inflammation in patients.

Our BET service involves the quantification of endotoxin levels in medical devices using state-of-the-art methods such as horseshoe crab lysates (LAL) assay. We adhere to the latest regulatory guidelines to ensure accurate and reliable results to help you meet your quality control requirements.

Typical applications for our safety testing include:

Fig.2 Typical applications for our safety testing.

  • Medical Dose Inhaler (MDI).
  • Artificial skin.
  • Respiratory pacemakers.
  • Insulin pumps.
  • Medical implants.
  • Syringes.
  • Needles.
  • Stents.
  • Catheters.
  • Sutures.
  • Surgical implants.

Why Protheragen-ING Lab?

  • Our comprehensive testing services help reduce risk and ensure the safety of medical devices, protecting patients from potential harm and adverse events.
  • By working with us, you can ensure that your device meets the necessary regulatory requirements to facilitate the approval process and market access.
  • Our rigorous testing process and adherence to industry best practices ensure that your device meets the highest quality standards, improving its reliability and performance.
  • We understand the importance of timely results. Our efficient testing processes and dedicated team enable us to deliver accurate and reliable results in the time frame you expect.

Contact us today to learn more about our services and how we can help you ensure the safety of your medical devices.