Changing medical device design control

Changing medical device design control First and foremost question comes why change? As you already know the change is so cumbersome and literally involves series of documentation.

However change is what you may want always. This may come from User requirement or marketing requirement or sometime your product has caused some issues in market which may be small but considering risk assessment it may turn out major in coming period.

Some part we may have visualized while designing but that time risk assessment might have considered it as minor but now feedback from market is forcing us to think about it.

-as a couple of examples--are all typically written and released at the start of a product's development.

What sometimes happens is these requirement documents are updated retrospectively to reflect what the team has learned the merchandise should be and requirements it should meet. This successively makes design control something that is seen as another item to be checked off to be complying.

Now question comes why we should not improve our process to visualise something in near future based on our own or others who are operating in the market.

In this current state of operation there are a couple of questions that require to be asked and customary habits that ought to be challenged. Just do not think of now only but think of future too.

Design control may be a methodology--not a documentation system. The methodology at its core requires user needs, design inputs, design outputs, verification, and validation of these outputs. So now design control needs close control on all such documents and review of the same in new situation.

When the essential reasons for a medical device are not regularly referenced, inefficiencies and therefore the company image which may get damaged due to increase in complaint or incident reported during post marketing surveillance. Those essentials and connections define what work must be done to bring a medical device to plug gap.

All essentially holds good if our document control system is electronic and tracking and tracing becomes very useful tool.