Like what many users have mentioned, involving regulatory experts and validation early into the development process is a way for organizations to find...

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or ...

If there are resource pressures or the lack of resources, during the planning stage, the project manager can identify what they need, what manufacture...

According to the FDA, the classification of a medical device is based on finding the regulation number that is the classification regulation of the de...

As many users under this post have mentioned, a balance of both the medical device’s own regulatory experts and an outsource to consultants would be t...

To begin, PMA is one of the most rigorous applications out there for medical devices that can pose-high risk. This typically includes performing pre-c...

There are slight differences between the works of a project manager and program manager in terms of scope, change, planning, management, success, and ...

Honestly at first, communicating in-person was the go-to method for companies, but it can be difficult to work fully in-person with a group of people ...

From many experiences with working in a project team as a member and as a leader, a lot of problems form due to miscommunication, misunderstanding, or...

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 companie...

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 ...

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 ...

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 th...

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

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 t...