Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification...

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory app...

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Desi...

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...