Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over m...

I believe that in some cases it's ok, where in other cases it's not. In the case of a drug that required an IDE, it might be a good incentive just in ...

In a double-blind study, both the Investigator and Patient don't know whether they're being given the placebo or actual results. In a single-blind stu...

I agree that providing clear evidence based data on safety and effectiveness is important for doctor's and patients. I think that patients want to fee...

Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either...

I agree that Sales and Marketing are important for Medical Device companies to meet the needs of costumers and deliver their final product to them. Ma...

In public companies, shareholders and investors motivate a large portion of the direction that Engineering goes to. In private companies, the manageme...

If I were to start a business, I would first consider how my business would make an impact in the industry, who are the consumers, and how who would i...

I agree that structure in corporations can lead to restrictions in their research goals. For example, corporations are meant to make money, and run by...

QA and QC often work together, even in the same departments. QA established the baseline requirements, and even makes a lot of the SOP's. QC does many...

In my experience, document control can always improve. For example, companies that still use a paper-based system should switch to completely electron...

I believe that emerging technologies would be very valuable in the field of QA. With the use of AI, quality management systems could improve by more e...

As a Quality Engineer, I had to the opportunity to perform tasks within Quality Management such as approving and modifying SOPs that adhere to GDP, an...

For higher class devices, more extensive clinical trials are needed to investigate the risk and effectiveness of a new device. For class 1 and 2 devic...

I think that newer technology facilitates more efficient Regulatory practices, while also raising more questions. Documents and meetings could be subm...