A patent is when we do/think of something unique and has not been done yet, only then we are eligible to apply for a patent. While an NDA is something that can be applied to the thing in which you own...

I think the gift restriction is a good thing as not all companies are at the same level in terms of their budget, one company has the best product but not much capital can easily fall short in pleasin...

A written agreement is the one done on paper and signed by the people agreeing on the contract/ terms within the document. A verbal agreement is when both parties agree to certain terms verbally and t...

So, we had decided to meet on video call as its difficult to manage to come for an in-person meet every week, we have completed the DDP, DID and have come up with Pre-Clinical, clinical and regulatory...

While forming a team I don't think getting a person who you know on a team will benefit unless the person is good at the job that he/she has to perform as in the end we want a completed project and do...

I would prefer working in a matrix organization as there is direct communication within the team and there are no silos nor is there any competition within themselves are they are assigned a simple ta...

For a low severity risk, we can accept the risk depending on its occurrence or try to mitigate the risk.While or the high severity of the risk should be either avoided but it will be a huge loss as it...

The first option is to design it out, which is ideal as the product is not in the market yet and if there are any design changes that can be done to reduce the risk then they should be adopted.The sec...

FMEA is ideally used for risk management as it gives an idea as to where and how the product might fail and what impact each of the failures will cause on the overall project.Also, rate each risk acco...

FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the manufacturer and have a look at the Design Control Do...

Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc which are essential in bringing a device in the ma...

Gantt Chart gives an idea of all the tasks that are needed to complete and project or a part of a project within a particular time frame considering the working hours, sick leave, time required for pr...

Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as to how the product will be built and there will be...

Design inputs are basically determined by the management, market research, users, Sales representative, and the research Scientist if he can make the product. The Design inputs are not specific as the...

Meeting minutes are written documentation for the attendees and the non-attendees to know what happened in the meeting and highlight all the important changes that were discussed in the meeting, addit...