An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices already have a level of technical documentation, however, the focus has been more on demonstrating current safety and effectiveness…   Read more»

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and ISO 13485) have greatly enhanced oversight and traceability, but I…   Read more»

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are viewed simply as a regulatory burden rather than a way to augment…   Read more»

You raise an excellent point on the significance of meeting minutes, particularly in regulated settings such as the development of medical devices. Throughout the design control process, minutes provide accountability and traceability by acting as the official record of talks,…   Read more»

Because it guarantees performance, safety, and regulatory compliance, design control is crucial to the development of medical devices. However, when applied poorly, it can result in serious issues such poor traceability between design inputs, outputs, and user needs. Teams run…   Read more»

In terms of design controls, the connection between the Design Input Document (DID) and the Design Specification Document (DSD) is essential to guaranteeing that a product is created methodically, precisely, and in accordance with legal requirements. In the process of…   Read more»

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that these companies and those building the device have the people’s health and safety in their…   Read more»

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the most important and basic information to include in a design matrix. They are all correlated to each…   Read more»

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and validation testing is done later in the…   Read more»

In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viability are more important. The teams should instead come together and collaborate discussing what…   Read more»

I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of information as you say. The most important thing to do in this instance to…   Read more»

The Design Input Document (DID) and Design Specification Document (DSD) are both important for developing a medical device, but they serve different purposes. The DID provides a broad overview of the product concept, describing what the device should do and…   Read more»

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»