One of the most elaborate prescriptions that the FDA has relates to the medical device product development process. This is because any error at any stage of the medical device product development process can result in serious repercussions for the patient. Since nothing is to be left to chance, the FDA has a series of steps in the medical device product development process. These are aimed at ensuring that there is total control of the device from the earliest to the last stage. All these controls are put in place to ensure that the manufacturer is able to locate an error at any stage and take remedial steps.
Starts with design control
The starting point of the medical device product development process is the design control process. These are a set of design control-related processes that the manufacturer has to take to make sure that the device is safe and serves its intended use. The purpose of having a proper design control system in place is to ensure that the manufacturer gets the device right through every stage and to make sure that redesign is not required at any stage. Such a scenario is something that has to be avoided, because this can result in waste of huge resources and thinning of margins.
The FDA’s requirements on medical device product development processThe FDA has an entire section, the US 21 CFR 820.30 aimed at ensuring that the medical device product development process is carried out in strict conformity with the set compliance requirements.
Roughly, the FDA’s requirements for the medical device product development process as stated in US 21 CFR 820.30 seeks to put the following requirements in place from manufacturers of medical device:
Design and development planning:This is a plan in which the design and development activities are planned by the manufacturer.
Design input:This stage of the medical device product development process takes into consideration all the parameters for making the medical device successful, such as safety, performance, risk, profit and so on.
Design output:This is a set of test, specifications or processes needed to check that the device functions properly.
Design review:The stage of the medical device product development process in which the device is thoroughly checked for defects and corrected.
Design verification:This stage confirms that the device design is able to withstand a series of tests and challenges and documents the results.
Design validation:This stage uses objective means to examine the device design and confirm if the design output meets the intended use, predictably and demonstrably over a period of time.
Design changes:These are to make sure that the changes, if and when they are incorporated at any stage of the medical device product development process, are approved and implemented.
Design transfer:The transition stage from device design to production while meeting specifications.
Design history file:A complete record of the stages of the history of the design process which demonstrates that the design was carried out in compliance with design controls prescribed by regulatory authorities.