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 non legal binding or possible…   Read more»

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 when taking one to dinner, I think…   Read more»

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…   Read more»

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 multiple projects…   Read more»

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…   Read more»

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 a goal” it is a large sense…   Read more»

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 lower because what does…   Read more»

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 are those with computational modeling of risks and…   Read more»

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 the customer and the…   Read more»

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 risk. And…   Read more»

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 being done…   Read more»

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 working with IEC/SC62A through Joint Working Group one…   Read more»

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 technical side any associated risks,…   Read more»

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 reference back to a specific date if…   Read more»

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 and discuss the progress…   Read more»

for instacne, science protocols are subjected to change, there are disputed methods in the scinetific communinty for thr exact protocol of proecdures and expirments being used. Also in business the change is indictive of the accountingmethods used for the design…   Read more»

this goes to validation vs verfiiction so from the regulatroy refrence site we have the following, “Validation is the process of checking whether the specification captures the customer’s needs, while verification is the process of checking that the software meets…   Read more»

Design inputs can be a wiede variety of notions, both physical and in the form of an implmented stragety like marketing inputs. A web search of design controls brings up the following ” Design controls designates the application of a…   Read more»

So while the document is not nessarly exactly like a DHF, a document similar to it is needed. Since the an origin of this document is the Formal Design Control and Design History File (DHF) requirements which are parts of…   Read more»