Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verification and validation both take outputs into account, but verification compares it with the inputs and validation compares…   Read more»

A simple example I can think of is a surgical wrench. This device would definitely require a torque test to ensure that it can apply the torque necessary for the procedures it’ll be used in. In addition to that, there…   Read more»

Most of the responses mention documentation in academia being things like lab manuals and lab notes. But if the research being done in academia is being used to develop some type of new medical device, would it be required to…   Read more»

I believe all changes must be controlled. Whether its a change in some type of documentation or a change in a design input leading to a change in the design of the device. In order to keep an accurate record…   Read more»

There has been much offered so far to answer the question “What are Design Controls”.Working at a medical device company fory  several years i would like to offer what i observed from my experience. Not necessarily a definitive answer but…   Read more»

A validation is not required if the product changes did not affect the user interface or clinical trial is not needed. It is necessary only for checking product specifications, interface standards and judging through end user’s perspective view. In my…   Read more»

Design verification and validation are main elements in design controls. Design verification is where the design inputs are verified with its output and all outputs must be verified. Whereas design validation is needed to check how well the device is…   Read more»

Insufficient design controls arise when the procedures are not followed properly or the standard procedures aren’t written. Insufficient design controls lead to the failure of the whole product. So the design inputs should be given about what is asked for;…   Read more»

FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the manufacturer and have a look at the Design Control Document especially…   Read more»

Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc which are essential in bringing a device in the market which is…   Read more»

Gantt Chart gives an idea of all the tasks that are needed to complete and project or a part of a project within a particular time frame considering the working hours, sick leave, time required for procurement of material from…   Read more»

Deign Control problems seem obvious only after adverse events, before that they are not so evident. Not starting out with a set of product requirements and do a top-down design the way the FDA expects is another factor that causes…   Read more»

In my opinion it will be beneficial if a particular pattern is followed while making a Gantt chart. Having the dates displayed right at the top for individual tasks apart for the entire project start/end date, while having the tasks…   Read more»

Verification and Validation are two different processes where validation follows verification. Verification is where you test/verify that the design outputs match your design inputs. It can include tests, analyses and inspections. Verification is typically making sure that you have objective…   Read more»

Design verification is a process that make sure the output is equal to the input ,It is confirmation by examination and provision of objective evidence that specified requirement have been fulfilled. Design validation ensure that user needs are met by…   Read more»

Minutes for meetings are very important for any project, During the each meeting the process of the project can be review, discuss some important points, Evaluate the project with the team member, discussing issues, making proposals, approving or rejecting offers….   Read more»

Verification is very important part of the project process, make sure you make verification accurate as possible. using verification we can check that a product, service meets requirement , can detect early mistake and fix it easy before it come…   Read more»

The main consequence of design control failure directly results of the failure of the product in market and may also affect the functionality of the product and then to make changes would result in delay of launch date. I remember…   Read more»

Minutes of the meetings are very vital as they give us an idea what exactly happened during the meeting and what critical decisions were taken not only it helps us recall what was happened during the meeting but also serves…   Read more»

I believe design control should be implemented in every step of the process from start to end of the product’s life. It is important to numerically or for some cases observationally be able to determine how well you are doing…   Read more»