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 it should be allowed to at least be able to pay for there partners dinner as well. This may lead to some strange…[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 the practical industrial aspect of biomedical engineering which is not tradationally taught in other classes, which makes this one invaluable and definetly…[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 then this would be a best thing to do as it allows the right balance of leadership and science in a mutally beinfincal way for the…[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 may not end up being your friends. In the professonal work enviroment some comprises have be made to get the project going and the work done. This includes…[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 it serve. Ok so the product has risk and an error, immediately think to fix the problem and mitigate the error in the best…[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 parameter values changing in stuff like survival analysis. Survival analysis is ” Survival…[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 public that the product is safe, effective and practical. This would increase sales and increase confidence in the product.…[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 this should be done without the thought for cost as a mandatory step and due process that regulations and companies owe to the public. It is…[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 effectively. Project managers often use these to enhance and make an inference as to the progress of the projects being done. It is…[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 (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51”

this is a…[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, even risks like, how will this device react with the body, will it make a reaction or cause one. Also the use of…[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 for instance, the boss wants to know who was in charge of this item. Or who suggested this idea. It is a form of b…[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 of the project and the necessary items that need to get done as well as the next steps and issues that arise. It has to do…[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 transfer, for instance if the design and schematics of this product is moved to…[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 the specification”

they are coupled in realtions just like QA VS QC but are…[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 formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to…[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 GMPs that were instituted and set by the FDA in 1996-1997. Similar design controls are required in europe. Europe does…[Read more]