ENSURE MEDICAL DEVICE SAFETY THROUGH BIOLOGICAL, CHEMICAL AND PHYSICAL TESTING

A medical device or material used in a medical device that comes in direct contact with a 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 deleterious 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.

IMPORTANCE OF TESTING OF MEDICAL DEVICES

Medical devices are essential when it comes to the healthcare and wellbeing of patients. Due to the diversity and versatility of the medical device sector, you need reliable quality testing services to ensure that your medical devices are safe to use.

Physical evaluations Generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.

Biological evaluations Address a device’s biocompatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.