Okay so discussing about "quality plan" for medical devices and so it outlines policies, procedures, guidelines, and activities relevant to that device. The manufacturer shall establish how the requir...

Yes I would agree that now days most important concern is about funding of medical devices in financial world and this would affect humans as all living beings indirectly rely on medical devices. It h...

I would talk about project based organization: There the most obvious advantage is that you have a direct control over the team. It has strong team structure and culture with the sense of identity. As...

Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are having objective evidence tha...

Project proposals is actually an idea that you give to a company for financial assessment to complete that project.The proposal exactly says about the plan of implementation of the project, giving inf...

As we know that medical devices regulations and processing is more challenging, I would like to discuss some challenges that I thought of like Regulatory Compliance and Securing Funding. Firstly looki...

I completely agree with Alexendrabuga, if a company want to be successful and if a company would think for a long term life of the company then they should not fraud by choosing a shortcut instead the...

As said for obtaining 510(k) the only requirement is to show that the instrument is similar that was developed before 1976 and they are classified under class 2 devices, but for PMA there has to be mo...