I would consider to set up the startup company as functional structure in the very beginning. As mentioned in lecture, this kind of organization is su...

I would like to work in a matrix organizational structure team. My understanding is that a matrix organizational structure is a company structure in w...

Based on ISO 14971 outlining the risk management process for medical device manufacturers, risk analysis is the systematic use of available informatio...

There could be multiple ways to identify risks. To my understanding, following lists can be considered: Identify the hazards that could possibly affe...

Some key points of ISO 14971: RISK - combination of the probability of occurrence of harm and the severity of that harm HAZARD - potential source of ...

I think meeting minutes are important. They capture the essential information of a meeting – decisions and assigned actions. They keep attendees on tr...

Hi, I found a very interesting intro online. Apart from what was discussed, some of other common problems that arise include the following: -Product...

In terms of design meeting, several points may be addressed: What tends to happen whenever a project issue arises? In most project review meetings peo...

ISO 13485 identifies design input requirements. These requirements are: Functional (7.3.2a) Performance (7.3.2a) Safety (7.3.2a) Statutory/Regulatory...

Medical device regulations are complex, but design controls are the most complex process in any quality system. The reason for this is that each of th...

According to FDA, 820.30(f) Design verification shall confirm that the design outputs meets the design inputs requirements. 820.30(g) Design validat...