Design control helps reduce potential risks by ensuring that every stage of the medical device design process is properly planned, reviewed, and documented. It allows teams to identify and address potential issues early, improving safety and performance. By linking risk…   Read more»

Design controls under 21 CFR Part 820.30 basically exist to make sure the device is intentionally designed, proven, and documented step-by-step instead of being developed randomly. Each part plays a different role. Design inputs define what the device needs to…   Read more»

Some examples of device changes that must be controlled include any change that can alter how the device performs, interacts with the user, or impacts safety. For example, changing a material inside a device (like switching to a different polymer,…   Read more»

I haven’t participated in an audit yet. The main difference between DHF and DHR is that The Device History File (DHF) includes all design and development records that show how the medical device was created, verified, and validated to meet…   Read more»

I think the best way to balance user needs with business limits is to acknowledge that both sides are part of the design problem. In class, we have gone over how the design begins with user needs but that doesn’t…   Read more»

Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve their market share. This is especially true when considering all…   Read more»

You’re absolutely right — design control provides structure and accountability throughout the medical device development process, but when it’s implemented poorly or insufficiently, several issues can arise. One major problem is traceability gaps. If design inputs, outputs, or verification activities…   Read more»

That’s a great point — keeping “living documents” like the DDP continuously updated is essential, but it can easily become overwhelming if not managed well. One effective approach organizations use is controlled versioning and scheduled updates rather than real-time edits…   Read more»

Yes, typically when an error is discovered in formal design documents like a DID (Design Input Document) or DSD (Design Specification Document), a change request is issued. This is part of the document control and quality management process to ensure…   Read more»

DIDs and DSDs are living documents, which means that if an error is found, it can be corrected easily. Since DIDs and DSDs are always being changed and reviewed, an error that is found early on may be corrected. In…   Read more»

Minutes in a meeting are extremely important because they can give deadlines for projects and assignments for certain tasks. Everyone must read the meeting minutes so they are up to date on the status updates on the different project tasks,…   Read more»

This is a really good point about the updating process of living documents within the medical device process. I think organizations can balance maintaining up-to-date documentation while preventing inefficiency or information overload by having the project team note down any…   Read more»