The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from material requirements to assembly instructions, and act as a single source of information for production teams to refer to….   Read more»

In the development phase of product development, the process of verification occurs. This process verifies that the product aligns sufficiently with the requirements in place. The process includes a variety of inspecitions and testing that serve to answer the question…   Read more»

Insufficient design controls can have negative repercussions on many aspects of the medical device industry, such as creating unnecessary costs, high defect rates, and in extreme cases, a company can be banned from producing insufficient products. However, the most prominent…   Read more»

Meeting minutes are essential for staying on track with a project and being able to recollect information. I have used meeting minutes for numerous courses and clubs I have been involved in on campus. Without the use of meeting minutes,…   Read more»

As many others have said, it is important to conduct the human factor study if the device is to be used in the human body. Although the guidelines may be general regarding what’d needed for these studies, conducting these would…   Read more»

As others have mentioned here, meeting minutes are useful for keeping the team in the loop as to what was discussed in every meeting. This is true, however, typically the project manager would send out tasks and dates associated with…   Read more»

Verification vs validation can be tricky to understand sometimes. Sometimes its helpful to view it as a ‘what makes sense’ in that moment when it comes up to verifying or validating a device. One example I can think of that…   Read more»

Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it down into clear sections that follow the product development process—like design inputs, outputs, verification,…   Read more»

Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issues and keep quality up. First, making sure the design, quality, and manufacturing teams communicate…   Read more»

Design Controls under FDA’s 21 CFR Part 820.30 are all about making sure medical devices are developed with safety, effectiveness, and compliance in mind. They help keep things organized and reduce the risk of errors, ensuring that the design meets…   Read more»

@jt63njit-edu I absolutely agree with you. Verification focuses on making sure that the software meets the specified requirements through activities like inspections or even reviews. It is often referred to as static testing in my workplace because it does not…   Read more»

Hi Saad,  You make a great point that design control is crucial for any medical device development as it ensures that the item is safe, efficient, and compliant with regulations. There are definitely challenges however, if the process is not…   Read more»

Hello Roberto, While I understand where Dr. Simon and many of these posts are coming from, I would like to play devil’s advocate and also recount a more negative aspect of meeting minutes. I have found in the past that…   Read more»

The responses seen above do a great job in explaining and describing the steps/process a team must take to define success criteria, but it is also important to highlight the disadvantages that come with moving target success criteria. To start,…   Read more»

This an interesting topic because there are so many medical devices that the 3 categories of design input requirements can be very different. The device that I will be mentioning is a pacemaker, which is a small, battery-powered device that’s…   Read more»

As many of the previous responses have stated, a project proposal is crucial because it establishes the foundation and direction of the project within a company. Not only does a project proposal clearly identify a business need and present a…   Read more»

Meeting minutes are one facet of the diamond I like to call personal responsibility in the workplace. It may seem tedious and unnecessary, but taking notes for every meeting or call is absolutely necessary. This is in addition to taking…   Read more»

From my work experience with a biomedical device that utilizes software, software validation is integral to the success of the device in the field. One issue with software that I have seen be dealt with is cybersecurity concerns. There have…   Read more»