As world population gets older and technology advances, there are more medical devices being used in all fields of medicine. These advances have contributed greatly not only to curing the illnesses we know about but also to preventing the ones we do not know about yet.
With such added emphasis on machines, the need to ensure that all such equipment function the way they are expected to gains more importance.
That is why so important. The Food and Drug Administration (FDA) has been helped by ISO 10993 biocompatibility standards that have stipulated exact medical device compatibility requirements.
ISO 10933 testing makes it easier to qualify for biocompatibility testing requirements of the FDA, including FDA 510 biocompatibility testing that is required for pre-marketing certification of all medical devices.
The FDA has gone to extra length defining what a medical device is and clearly states that, “If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration as a medical device and is subject to pre-marketing and post-marketing regulatory controls.”
Biocompatibility testing for medical devices is not an easy task. There are many requirements that need to be abided by, their interaction with human body examined, and results extrapolated over a period of time, mistakes corrected, and the machines retested again.
Such testing for some equipment might not be easy but when a devices is comprised of many parts; the testing need and its importance for our health gains extra importance.That is why testing for medical devices are done with help of many biocompatibility testing laboratoriesand companies. One such company is as Biocomptesting (http://www.biocomptesting.com) Biocomptesting performs biocompatibility testing for California companies and other nationwide.