Ensuring Your Medical Device Meets the Highest Standards: Why and When to Test

In the world of healthcare, ensuring the safety and efficacy of medical devices is paramount. This is where medical device testing comes into play.

Why test your medical device?

There are several reasons why testing your medical device is crucial:

To comply with regulatory requirements: Medical devices must meet stringent safety and efficacy standards set by regulatory bodies like the FDA. Testing is essential to demonstrate that your device meets these requirements.
To identify and mitigate potential risks: Testing helps you identify potential risks associated with your device, such as adverse reactions, unintended interactions, and performance issues. This allows you to take corrective actions and improve your device’s safety.
To enhance product quality and performance: Testing can help you identify areas for improvement in your device’s design, materials, and manufacturing processes. This leads to a more reliable, effective, and user-friendly product.

When should you test your medical device?

There are several points in the medical device development process where testing is essential:

Preclinical testing: This initial testing is conducted before clinical trials to assess the biological safety of your device.
Clinical trials: Medical devices undergo clinical trials to evaluate their safety and efficacy in human subjects.
Post-market surveillance: Once your device is on the market, you are required to conduct post-market surveillance to monitor its performance and identify any potential problems.

Partner with NABI Labs for comprehensive medical device testing

At NABI Labs, we offer a comprehensive range of medical device testing services, including:

The biological evaluation plan (BEP) outlines the approach employed to manage biological risk, specifically addressing biocompatibility concerns, associated with your medical device.
Biocompatibility testing: Assesses the interactions of your device with human tissues. At this stage we deliver tests suitable for your medical device (i.e. chemical characterization (extractables & leachables), in vitro testing (cytotoxicity, genotoxicity, hemocompatibility), in vivo (irritation, sensitization, pyrogenicity, toxicities, implantation, carcinogenicity)
The biological evaluation report (BER) is an effect of our work. It’s a summary of data used to demonstrate how compatible a medical device is with the human body. In other words, the BER provides evidence of a medical device’s biological safety, known as biocompatibility.
We can offer you regulatory compliance assistance: Guide you through the complex regulatory landscape, support you in case of difficulties or negative test results, advise you on your medical device production process, and more.

We are accredited to ISO 17025, the gold standard for medical device testing laboratories. We also adhere to strict Good Laboratory Practice (GLP) guidelines to ensure the integrity and reproducibility of our test results.

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