I believe that the design inputs can be  obtained from marketing team on what type of product is required in the market in collaboration with the suggestions added by scientific experts as the product is designed for customer it must…   Read more»

Design inputs require you to have knowledge of how the device will function. This depends on the design, shape, and what the device is made to do. Design inputs are base for the device you want to create as you…   Read more»

I believe some way to record what has been discussed in meetings are extremely important in terms of team success and organizations. It does not necessarily have to be in minutes. However, it is one method where one can read…   Read more»

For any new device, it should be good practice to always have a way to test and minimize errors or risks before the product is sold to customers. It is extremely important to do this before and well. Since once…   Read more»

Meeting minute are import part of meeting when you are discussing something important because they let you see what you talk about in the meeting so everyone is on the same page. When developing new device it is important to…   Read more»

Design controls are FDA guideline which you need to follow when you begin creating your device. This guidelines help you understand weather your device is safe to release into the market. It is way easier to follow this guidelines while…   Read more»

The sources that help determine design inputs can come from a variety of different areas such as customer feedback or intended purpose of product. For example, if feedback gathered from target consumers show the need for a compact product, the…   Read more»

The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. The elements of design controls are – planning, input, output, review, verification, validation, transfer, design changes…   Read more»

If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, safety, and revenue generation. However, misuse or lack of certain design controls steps can prevent a…   Read more»

Verification is an important part of design controls since it ensures that the inputs match the outputs. It is a way to test the quality and consistency the products, making sure that all the design features of each tested sample…   Read more»

The main difference between verification and validation is the end user. Verification is more or less a premarket step that distinguishes between the design inputs and outputs. This looks to answer the question of how closely the current design matches…   Read more»

Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During the planning phase, the project proposal gives management a broad idea of the project scope, demand…   Read more»

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

I was the secretary in my undergraduate BMES and among my roles was writing minutes for all our meetings. This was an important task as it gave us in charge the ability to check back and corroborate any future decisions…   Read more»

Posted by: @rgp29 Hello everyone,I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was in…   Read more»

Posted by: @hg93 As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides…   Read more»

Verification is an important aspect of design controls that puts the claims and specifications defined by the project team to the test. In a general overview, verification helps assess a product meets both quality standards and performs as outlined prior…   Read more»

Verification is very important as we need the design parameters to match with the proposed designs to avoid any faulty or any unavoidable damage. To make verification better i think the process should be very neat and strict without any…   Read more»