FREE ON-DEMAND WEBINAR
Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the EU MDR (formerly MDD) include similar requirements as well.
Yet, although manufacturers have design control processes in place, they are not always effective as failure to follow design control requirements is commonly cited in FDA 483’s and warning letters.
Clearly just having design controls in place and understanding what the regulation says is not enough!
We must also understand what design controls are trying to accomplish, i.e., why they exist, in order to avoid problems.
At the end of the day, design controls should not be about a hard and fast set of rules… rather, it’s about understanding the intent and approaching the process in a logical and systematic fashion. In other words, don’t just follow the rules… think!
Upon completion of this webinar, attendees will have an understanding of the design control “framework” and recommendations to effectively meet their requirements.
Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.