We engineer high-quality, compliant pre-production clinical units to accelerate your path to market

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“Pre-production clinical units” typically refer to early batches or units of a medical device or pharmaceutical product that are manufactured for use in clinical trials. These units are produced before full-scale commercial production begins and are specifically intended for testing in a clinical setting. 

Throughout this process, collaboration between manufacturers, clinical researchers, and regulatory authorities is essential to ensure that the pre-production clinical units meet the necessary standards for safety, efficacy, and quality. The goal is to gather sufficient data to support the product’s regulatory approval and eventual market launch.