I’d like to focus on the Fault Tree Analysis (FTA), which is a method used to explore the causes of system level failures. This method consists of two elements which are “events” and “logic gates.” Th...

The FMEA tool is a great way to identify potential problems and their impact. It is a qualitative systematic tool used to anticipate what may go wrong, in addition to the likelihood of failures being ...

I believe that risk is acceptable in situations where a patient’s health is in question. For instance, if someone is experiencing symptoms that are associated with a stroke, completing an MRI is very ...

Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification an...

When designing a medical device, customer needs and deign output are both important factors. Design controls ensure that the device meets the user’s needs, intended uses and specified requirements. De...

Countries such as Europe, Canada, Japan, Malaysia, Singapore and Australia have Design Controls and require ISO 13485 certification. European companies who are active in the EU market are expected to ...

Informed consent is very important within research. This ensures that the purpose of the research has been explained to the patient, along with informing them of what will be done to them, how the pro...

Transitioning from R&D into clinical research or vice versa should be a smooth transition since both careers involve a research study, business insight, developing new products/treatments to impro...

Clinical research is a great way to test new treatments and see how they effect patients in an ethical manner. Some advantages to clinical studies are that you may be able to access new treatments, th...

Clinical research is a great way to test new treatments and see how they effect patients in an ethical manner. Some advantages to clinical studies are that you may be able to access new treatments, th...

Graduating from college and trying to find a job isn’t the easiest task, but it is rewarding once complete. I didn’t know exactly what I wanted to do for work upon graduating, but I knew I wanted a jo...

It is important to conduct research on a company prior to accepting the job. I have received job offers and emails from companies recruiting me to become apart of their team, but once I did more resea...

I currently work in Quality Control, and a typical work day is as follows. I come in the lab, check my emails and look at my scheduled testing. I put my lab coat, safety glasses, and gloves on then I ...

@mayasaunders You mentioned some valid points. There is something my department called “continuous improvement,” meaning we are always looking for new, innovative ways to improve methods and procedure...

Quality Control is extremely important for ensuring products are performing at their optimal level and to catch mistakes before they get on the market and in the hands of patients. Quality departments...