Medical Device Biocompatibility Requirement
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 laboratoriesand companies such as Biocomptesting (http://www.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...