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

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or intended use, satisfying the acceptance criteria. ...

If there are resource pressures or the lack of resources, during the planning stage, the project manager can identify what they need, what manufacturers produce those resources, and how abundant they ...

According to the FDA, the classification of a medical device is based on finding the regulation number that is the classification regulation of the device. Project teams have to use a classification d...

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 the best in both worlds. Both regulatory experts an...

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-clinical and clinical trials to ensure the safety a...

There are slight differences between the works of a project manager and program manager in terms of scope, change, planning, management, success, and monitoring. Overall, they are kind of similar to e...

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 working on a project. Working under a project mana...

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 the lack of communication between team members. A...

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...