Posted by: @hzy2 Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for steril...

Posted by: @sahitya-sadineni Part of FDA's mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statem...

Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it...

Posted by: @hjp39 With the way everything is headed now, several departments have gone full time remote such as complaint handling, some regulatory positions, and even few Quality Engineer positions ...

Posted by: @sseal98 With the increasing integration of computers to our daily lives as well as into the medical device and biomedical engineering discipline, should it be required from students in BM...

Posted by: @karen-immanuel Hello all, I was just curious as to what level of education is best before getting into industry. My thoughts are that BS is good enough to employ you with basic skills and...

Another great way to help is to put more funding into the development of alterative testing models. A great example would be organ on chips. This is a type of biotechnology they is able to replication...

The animal variety can influence the reproducibility of a pre-clinical research because the models are different. How a medication works in on animal may not work the same way in another animal. This ...

The areas that are important to me would be; The budget amount they are requesting. The budget break down. The price research and comparisons and the purpose for each expense that they are requesting ...

Quality assurance is the combination of administrative and procedural activities implemented in a quality system that are meant to ensure that a goal is completed are a project is fulfilled. While qua...

@sfrancis Francis, Great reply to the post. It is really amazing to see that you actual have real world experience with this. Because it is easy to give a test book answer to this problem to to actua...

Well if I was the project manager in this case I would have planned for 2 to 3 employees leaving during the course of this project. So, them taking a vacation should not effect the over all progressio...

Posted by: @ap962 The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively? Doing the c...

Posted by: @mejefferson During the planning phase of project management, both time and money are crucial. Timewise, the longer your product takes to develop, the more money you will have to seek from...

Posted by: @devarshi-joshi After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem? After the de...