Design inputs acts as a foundation for the medical devices so this becomes necessary for any device to get into market. I agree that getting inputs right is the most important thing for developing an device. Desihgn inputs comprises of requirements, criterias for performances, features and needs of the product. Few goals to consider are 1) capture…[Read more]

As we know Monitoring and Controlling is one of the phase of project management. It includes tracking, reviewing the performance of the project going on and looks at the changes required. This phase itself contains 11 processes like: 1) generic process whre all monitoring and controlling is done. 2)task involving changes to the plan. 2)process…[Read more]

Risk management meetings always have the content that says about bad things going to happen and also about thinking about all adverse effects going to happen paper-works and formal procedures. So in this if I was a PA I would ask everyone to think about the risks associated. I would expect that ongoing battles would be controlled. I would even…[Read more]

Packaging, Testing, & Documentation plays essential role for any project for a company. For Testing the steps are: Repeatability, Reproductivity, and Sensitivity then for Qualification they firstly look at testing to aid critical processes(instrumentation qualification), secondly it tests upper & lower parameter limits to ensure properties meet…[Read more]

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 requirements will
be matched. Summarising I would say that quality plans are powerful tools in demonstrating compliance. But not writing it properly would…[Read more]

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 has become difficult to gain investors attention for convincing them for finance. Money are going mainly into non med-tech sectors. The reason…[Read more]

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 whole team focuses on the teams goal so there is less conflict and even scheduling the time for workers becomes easy. In this organization you get…[Read more]

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 information about the project, ways they will manage it and lastly the results that will be delivered from it.Its all how you plan your action and a…[Read more]

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 they should go with the regulations and whole procedure ethically.

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 more trials on humans or animals and documents about its efficiency and safety has to presented supporting the experiments or we say trials done on…[Read more]