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Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all  medical devices  to stringent conformity assessments. Moreover, the onus of classifying a medical device is the responsibility of the medical device manufacturer. The device manufacturer has to be aware about the class under which their device will fall under, right from the time the device is in the process of development. Philosophy of Medical Device Classification In terms of practice it can’t be economically justified neither is it feasible to form all medical devices undergo every stringent assessment in terms of conformity. A system of control which is graduated should be quite enough. Under the tenets of such a system, the degree of control matches with the degree of possible risks innate within a selected device type. This warrants the necessity for a system for classifying medical devices. Th...

The Need for PMS Post Marketing Surveillance (PMS) are often defined because the process of identifying and gathering information concerning medications or medical devices after it's been approved by the concerned authorities like the Food and Drug Administration (FDA) within the US. With regards to medications, a scientific PMS process commenced way back within the early 1970s and since then, there has been a considerable increase in PMS. Drug and medical device monitoring following the method of approval has become mandatory for several reasons (FDA, 2020). Way back within the past during the 1950s and 60s, the amount of medicine within the market were very scant compared to today which made monitoring a rather easy process. within the present day, drug manufacturing has assumed magnanimous proportions and is being consumed at a really high rate. Several other factors that warrant the necessity for PMS pertains to the modifications within the approval process of the FDA....