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Medical Device Biocompatibility Requirement (2015-06-15)
The world of medicine has gone through astronomical changes in the past decades. It has become more specialized. It has taken great strides towards better use of technology and the mechanization of the profession as a whole.
Before any medical device can be offered commercially, it has to pass the FDA 510 biocompatibility testing for pre-marketing certification. Biocompatibility testing for FDA has to be based on certain biocompatibility testing matrix.
Medical device biocompatibility testing is done by biocompatibility testing laboratories and companies such as Biocomptesting (biocomptesting.com), one of the biocompatibility testing companies in California.
In ensuring safety, the FDA relies on the ISO 10993 biocompatibility standards and ISO 10993 biocompatibility testing requirements.
Testing medical devices according to ISO 10993 testing guarantees the safety of these devices that could have serious public health issues otherwise.
Biocompatibility testing for medical devices could have implications for people with whom they come in contact in part because some of these devices, like a pacemaker, are made up of multiple parts, each of which could be rejected by our natural body mechanism.
Medical device testing, of course, is more than just performing biocompatibility tests.But these tests are important. In the words of the FDA, , “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 (FDA) as a medical device and is subject to pre-marketing and post-marketing regulatory controls.”
Biocompatibility testing not only is important but it also has become a very specialized and technical field. Just as there are so many variations in the medical profession as a whole, testing devices for each of those fields have become numerous. That is why the wholehearted effort of companies such as Biocomptesting (biocomptesting.com) matter to all of us.
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