As a follow-on from Octobers blog on “Software developers – design controls matter”
Design controls are a crucial element of a medical device manufacturers quality management system. It covers the life of a device from concept to commercialisation. Design control applies to all changes to the device or the manufacturing process design, including your sub-contractors. But it doesn’t stop there . . .
Implement design controls early, rather than later – these controls will support the development cycle, not hinder it. Don’t think it will be done later, it won’t happen – either the information required to show compliance will be lacking, or worse, lost . . . and don’t think it’s not needed, it is!
At audit time – if there isn’t a record, it didn’t happen – see this example of a warning letter of what you don’t want to be receiving.
Design controls apply to all changes to the device or the manufacturing process design, including those occurring long after a device has been introduced to the market, in fact right up to obsolescence.
Changes are part of a continuous, ongoing effort to design and develop a device that meets the needs of the user and/or patient. Thus, design controls is a living process supporting the life of a product and the processes that realise it.
Visit our video gallery to download a copy of the slide or the download the webinar to hear Senior Consultant Peter Austen explain what you need to do while in the development phase.