Medical Device Safety Testing - Protheragen-ING Lab

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.

Microbiology Testing - Bacterial Endotoxin Testing (BET)

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.

Microbiological Testing - Sterility Testing

This test is suitable for use on medical devices with a sterility declaration.

Protheragen-ING Lab follows strict protocols to detect the presence of live microorganisms on or in medical devices. We use a variety of methods, such as membrane filtration and direct inoculation, to assess the sterility of medical devices and ensure that they meet the highest safety and quality standards.

Microbiological Testing - Bioburden Testing

Does your manufacturing process meet your microbiological quality and sterilization requirements?

Protheragen-ING Lab offers bioburden testing or total viable count testing to help measure the level of microbial contamination on the surface or inside medical device products.

Microbiological Testing - Microbial Identification

Rapid identification methods for microorganisms in medical device manufacturing and packaging environments are critical to an organization's contamination control and mitigation decisions.

Protheragen-ING Lab offers a wide range of microbial identification methods. These include selective media, microscopic examination, Gram stain tests, MALDI-ToF mass spectrometry, and gene sequencing.

Microbiological Testing - Antimicrobial Effectiveness Testing

This service helps evaluate the ability of medical devices to inhibit or kill microorganisms such as bacteria, viruses or fungi. This testing is important to ensure that medical devices with antimicrobial claims are effective in reducing or preventing microbial contamination.

Packaging Testing

Our packaging testing services assess the quality and effectiveness of packaging materials to ensure they provide adequate protection during storage, transportation, and use.

This testing involves evaluating factors such as package integrity, microbial barrier properties, and compatibility with sterilization processes to ensure the safety and reliability of medical device packaging.

Regulatory Support

Protheragen-ING Lab offers regulatory support services to help you meet the necessary compliance requirements. Our team of experts stays abreast of the latest regulations and can guide regulatory strategies, document preparation, and submission requirements. By utilizing our regulatory support services, you can streamline regulatory processes and ensure compliance with applicable standards.

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.

Services