I suppose it would depend on the sitution, if a stated specific agreement has to be met with legal implications and monatary value on the line then a written agreement is needed. However when other no...

Correct, this is to impose and ensure ethical manners in the busniness world, even though the intentions may be well it still may lye other intenetions. which may not be approbriate. However espically...

This course has been a great one, that taught me the ins and outs of the medical devices and the logistics behind it. i enjoyed the course a lot and learned so much. This gave me an idea as to the pra...

I still like the matrix organization, as it induces proper work flow and opens the fied for the employess to get the job done. Ideally if you would want the goal of being larger company that works on...

Well in the real world senerio you usually do not pick who you end up working with and it always best to work with those who have the right skill set to do the job and project needed. And these may no...

So the company I would like to be in is a matrix organization because a matrix organization is one that " brings together employees and managers from different departments to work toward accomplishing...

I do feel, though that prediction is the very crucial to the risk Management, as mangers like employs who are proactive and can spot mistakes and risks early on before they happen. I say acceptance us...

Involving in risk analysis is a serious task, and often requires a large amount of personnel working simultaneously to properly analyze the associated risk. as such, workings in some companies if seen...

I agree with the last one in the sense that companies should, if they don't already do, perform risk analysis and risk management on the product all throughout the product lifecycle as a way to ensure...

I agree, essentially it is this, that a company should do what it reasonability can to ensure all risks are assessed and ensure no negligence is done on the part of the company to put the users at ris...

Hello, Good point, they should be quite detailed and yet not overly complicated as to confuse the reader, it is essentially a form of management that is done to make sure tasks are on the way and are...

A search revels "ISO 14971 is an ISO standard for the application of risk management to medical devices.The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 worki...

The risk assessment can differ from various ways, they typically may have someone who is acquainted with the field but look an analyze the device from top to bottom, every inch to check from a technic...

Meeting minutes are import as a form of almost quality control for meetings; it’s a form of accountability and covering for everyone. As someone who is taking notes of recording the meeting can refere...

Hello, The meeting structure is very organized, with a moderator and someone taking notes to reference in later meetings who said what. It is essentially a time to get everyone in one room to work on...