If you're a manufacturer that's beginning the process of bringing a medical device to market, you'll definitely need to work with a microbiology lab to verify the integrity of your product and do early-stage testing. Early tests on biocompatibility, sensitization, irritation, sterility, and toxicity, as well as package integrity tests can and should be performed by a high performance lab equipped to handle a wide range of early-stage processing. Successful manufacturing of a medical device requires abiding by strict quality control standards, so that your device can be true to it's function with less chance of being compromised. So if you have a prototype or have already initiated production, here's why you need a testing lab to back up your device when it goes to market.
The FDA has strict regulations that determine how a product gets from design to market. Every product that's destined for health or medical applications has to demonstrate that it's been tested using stringent guidelines under the auspices of a certified lab. Not only does your device need to demonstrate compatibility with human usage, but even the packaging must be qualified to meet integrity standards.
Medical device testing labs offer you the best chance of gaining product acceptance, because they are required by law to maintain equipment and personnel to an absolute level of quality control standards. Laboratories that keep equipment calibrated, data available, and certifications current abide by the standards regulating medical testing itself, so sending a product to them will ensure that you don't run into an FDA audit later.
It Demonstrates Effectiveness and Product Integrity
Medical devices should always be accompanied by honest and accurate assessments of it's efficacy, and if anything anomalous was witnessed in testing. This helps to clarify issues that may potentially arise in certain individuals, like an allergic reaction, irritation, or bioincompatibility. If your can clarify what was found in testing your medical device, it can better reach a target with the least chance of causing adverse reactions.
Brand Fidelity Depends On It
When you can provide consumers with a guarantee that your product will do what it says it should without causing harm, they may be more inclined to choose your products or devices over other brands time and time again. Brand fidelity requires that you can back up your statements of product efficacy, quality, and integrity, so consumers readily identify your company as one committed to good manufacturing practices.
To get your medical devices tested, consider contacting a local specialist, such as Nelson Laboratories, to discuss any of your concerns.
3 November 2015
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