Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done. As said in your question, validation is often not required if it can be argued that the…   Read more»

Unlike in the US, design controls are not required in Europe to release a product. I personally prefer the American method of requiring a DHF and DMF, specifically when the DHF is treated as an unchanging document while the DMF…   Read more»

This video was absolutely hilarious while getting its point across. It shows how when people don’t understand the project they go off on tangents that are impossible to pinpoint. This makes completing the project incredibly difficult. They rely on the…   Read more»

Some colors that I notice a lot are blue, green, and white. I think these are great colors for companies to use. These colors all draw the eye very quickly. For example, when I think Apple, I think white. White…   Read more»

This is an interesting topic you raise. I believe that there is a factor of manipulation needed to really promote a product and sell it to a person. However, I do not think it is a bad kind of manipulation….   Read more»

Most of us have attended a meeting madly scribbling what we thought were meeting minutes only to find out later that we’ve missed important information of that the notes we took were never used. Minutes that capture the purpose of…   Read more»

The completion of process validation is a regulatory requirement that a manufacturer must adhere to. But in some cases as mentioned above the validation is not required .The main goal of human factors validation testing is to demonstrate that the…   Read more»

Design controls are the means a medical device developer uses to prove that a product is safe, it works, and it is suited to the needs of the market. The following are points that justified by design control that the…   Read more»

Just like the Human Repeat Insult Patch Test (HRIPT) is carried out in clinical study and on product (mostly OTC) just to see if any allergic reaction might have developed over the years. Also, the Human factor study is needed…   Read more»

The Business requirement document I will say is the combination of the Design Input Documents (DID) and the Design Specification Documents (DSD). Business requirement document just like what have been said above is a major requirement and guide to a…   Read more»

I have had a few experiences in which I have been required to create Gantt charts, and I have found that it was an excellent representation of a project’s schedule in terms of tasks that need to be completed. Personally,…   Read more»

Disorganization and lack of planning and distributing of tasks can tear the design control system down. The nine steps of design control need to be implemented per code. When the process is not followed completely or specifically, it can cause…   Read more»

To make this simple, design control makes sure that there’s a plan set by the company or manufacturer that has to be implemented and makes sure all requirements are met during development. By doing so, design control protects patients from…   Read more»

Meeting minutes are crucial for assigning tasks and for each person to know what their task is if it is unclear. Also, meeting minutes give information on deadlines and what actions should be taken at each step of the way….   Read more»

When first trying to brainstorm an idea, you would want to think broadly. You want to get an idea for a product that would be useful for patients or customers. More specifically, you would want to know what specifically customers…   Read more»

Personally speaking, I never understood the importance of keeping meeting minutes until I started working in larger, more complex groups where many tasks needed to be completed. Meeting notes are great for having documentation that can be referred too if…   Read more»

If you asked me before working for corporate I would probably say meeting minutes are just repetitive and there is no point for them if you already attended the meeting. However, they play such a big role in referencing certain…   Read more»

@sts27 I agree, in my opinion, I do think in academia different departments have different regulations. For example, I do believe the life sciences department could have different regulations than the engineering department. An example of regulation needed for engineering…   Read more»

I write down almost everything discussed during meetings. Not all of the information is useful, but doing such both helps me remember the meeting better and provides a basis for writing my weekly plan. In all honesty, I would say…   Read more»

In all honesty, I think it depends on the nature of your research. If you are working with animals or humans then comparative documents would be IRB approval and approval from animal review boards.  If you view it from a…   Read more»