Biologics

Biologics

Minnesota MedTec tries to minimize the amount of costs during its manufacturing processes however, many costs can’t be avoided when medical devices are concerned.

Medical device or materials used in a medical devices that comes in direct contact with a human patient must be able to perform its intended function without inducing significant rejection or adverse reaction in a patient. The degradation or leaching of chemicals and other device materials may lead to effects on a patient, and potential adverse reactions can range from the rejection of the device by the body to longer term reproductive or developmental effects.

For these reasons, medical devices and materials are typically subject to a range of biological, physical and chemical tests to ensure that the benefits offered by the device exceed any potential risks to a patient as a result of the device itself or the materials used in the device.

Facility design and control considerations for commercial manufacturing processes include environmental controls (e.g., temperature, humidity, and pressure), air quality (e.g., particulate and microbiological), facility finishes, gowning and flow procedures, equipment containment, system integrity, and cleaning procedures.

At Minnesota MedTec, we evaluate the risks when we receive orders from our customers and produce the products based on their requirements.