NDA standards for Non-Disclosure Agreement and these are common agreements between companies to protect confidential information and trade secrets. It is a basis of consulting with and interaction bet...

What others have said about a mandatory ethical compliance clause, single enforcement system, standardized dispute resolution mechanism, uniformity, and consistency are all valid major requirements th...

If I were to be the owner of a company and something were to happen to me, yes, I would think it would be beneficial to have a mapped out plan of legal proceedings and how to handle deals when I am no...

With what the original post had mentioned, I agree that both the Gantt Chart and Network Diagram are necessary for project teams to have. There are a lot of cases where projects mainly have a Gantt ch...

As the original post mentioned, I also have not ventured into a device development job. I think functional organization is the “worst” one for me to strive in because I am not too keen on working with...

I would say that the most applicable development strategies would be evaluation, analysis, and adjustment. They would evaluate the current situation of both the company and the development process, an...

As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, bu...

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our projec...

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or me...

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that these companies and those building the device have t...

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the most important and basic information to include in...

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and va...

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications a...

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note ...

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadli...