In my opinion, I believe the importance and usefulness of standardized design controls is that it necessitates the project team to question every detail of the project as well as document every aspect of it. In relation to questioning every…   Read more»

I certainly think that Minutes for Meetings(also known as MoM) are quite useful and must always be prepared during a meeting , as later on it plays an important role for maintaining the project towards the specified goal. When i…   Read more»

Design Controls are a part of 21 CFR part 820.30 which are presently adopted into the ISO 13485:2016 standard to ensure that the device or the even a component that you are making follows the design control process as it…   Read more»

I guess the sources of design input will depend on a number factors such as the customer requirements who can be doctors or patients, safety, similar designs from previously manufactured devices and their designs, market research and so on. After…   Read more»

Minutes of a meeting are essential. They contain the important points discussed in the meeting. It contains the necessary action items and the assignee for the action item which one would tend to forget after the meeting has ended, but…   Read more»

I don’t agree with you. I think every part of the design development plan plays an equally important role. This will make your whole plan rigorous and organized, and help the project go on more efficiently. As Dr. Josh said…   Read more»

Based on my internship experience, I think the design review meeting is very important. In this meeting, everyone will discuss about the part that they are responsible for, and at the same time, they will have enough understanding of each…   Read more»

Hi RobertoDuring my internship, I only read the email of the meeting process quickly, and some of the content is particularly important in the whole project. If you neglect the important parts of the meeting in the project, it is…   Read more»

In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the meeting will send out an agenda with the meeting invitation. He or she usually…   Read more»

From my experience, meeting minutes are extremely beneficial for resolving conflicts over matters that were discussed in the meeting. Any time an issue that was previously discussed is brought up following a meeting, it is often the easiest to resolve…   Read more»

As an R&D Engineer, I work with a lot of the types of documents that were described in this weeks lecture. For our Design Input Document (DID) we have a document called a Market Specification, which identifies the market requirements…   Read more»

Most of the posts above explain the difference between verification and validation well. If there is still confusion on it, an example that I’ve found helpful is say you’re designing a new tool for surgery. Based on discussion with a…   Read more»

When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is often called a Root Cause Analysis. In a root cause analysis the failure is…   Read more»

I’m currently working on a project for my undergraduate senior design project in which we are creating the prototype for a new medical device. For this project, my team is working our way through the 9 parts of the Design…   Read more»

Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as to how the product will be built and there will be a lot…   Read more»

Design inputs are basically determined by the management, market research, users, Sales representative, and the research Scientist if he can make the product. The Design inputs are not specific as the DSD is responsible for the exact specifications for the…   Read more»

Meeting minutes are written documentation for the attendees and the non-attendees to know what happened in the meeting and highlight all the important changes that were discussed in the meeting, additionally, it helps to keep a track of the timeline…   Read more»

This is one of the most important part of the medical device project. The design development plan describes all the design controls, project layout and project scope. The plan describes all the team members including roles and responsibilities. This is…   Read more»

Design inputs are starting point for product design. The requirement which form the design input establish a basis for performing subsequent design tasks and validating the design. The development of a solid foundation of requirements is the single most important…   Read more»

Design controls are mandated by FDA in the year 1996 and defined in FDR 21 CFR 820.30. It monitors the steps in designing and creating the medical device. It demonstrate the medical devices are safe, effective and meet the indications…   Read more»