Conception and Development
-In conceptualizing a medical device, scientific principles must also adhere to its safety and performance. As such heaps of work on researching is very significant.
The more complex the device, the higher the possibility of it’s being susceptible to errors and pitfalls. Reliability and accuracy of concept and competence over design, testing and construction call for analysis of experts so as to ensure that all of the design parameters don’t entail any risks and hazards.
-Manufacturing
Handy medical devices are created when all the manufacturing processes are carried out properly and managed adequately. On the other hand, poor manufacturing management often result in discrepancy of products.
Since “good manufacturing practice” is stressed out and mandated in the process, guidelines are developed and created.
-Packaging and Labeling
Since the product has been conceptualized, manufactured, produced and surpassed FDA regulatory guidelines, the next step involves packaging and labeling. Packaging system involved polishing the product for public use.