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 suitable for small startup and advantages are obvious: Functional departments arguably permit greater operational efficiency because employees with shared skills and knowledge are grouped together by…[Read more]

I would like to work in a matrix organizational structure team. My understanding is that a matrix organizational structure is a company structure in which the reporting relationships are set up as a grid, or matrix, rather than in the traditional hierarchy. In other words, employees have dual reporting relationships – generally to both a…[Read more]

Based on ISO 14971 outlining the risk management process for medical device manufacturers, risk analysis is the systematic use of available information to identify hazards and to estimate the risk. In order to do so, company may need to define the scope of their medical devices, to specify the intended use of the product and to identify hazards…[Read more]

There could be multiple ways to identify risks. To my understanding, following lists can be considered:

Identify the hazards that could possibly affect the safety of your medical device.

Document the known and foreseeable hazards that could affect the safety of your medical device.

Use your risk management file to maintain the documents that…[Read more]

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 harm
HAZARDOUS SITUATION – circumstance in which people, property, or the environment are exposed to one or more hazard(s)
HARM – physical injury or damage to the health of people, or damage to…[Read more]

I think meeting minutes are important. They capture the essential information of a meeting – decisions and assigned actions. They keep attendees on track by reminding them of their role in a project and clearly define what happened in a group session. I found there are some common tips that should be pay attention for meeting minutes.

Before t…[Read more]

Hi,

I found a very interesting intro online.
http://www.mddionline.com/article/preparing-successful-design-transfer

Apart from what was discussed, some of other common problems that arise include the following:

-Product developers do not have a finalized design.
-Business managers and technical experts do not grasp the scope of the design…[Read more]

The effectiveness of the best-conceived design transfer process will be diminished if it is not properly supported and carried out. Some of the more common problems that arise include the following:

-Product developers do not have a finalized design.
-Business managers and technical experts do not grasp the scope of the design transfer effort and…[Read more]

In terms of design meeting, several points may be addressed: What tends to happen whenever a project issue arises? In most project review meetings people immediately begin to discuss the issue. What is the chance that this will be the most important issue to be discussed? What is the chance that everyone in the room will share a common…[Read more]