To give yourself the 'ultimate protection' from having your idea stolen, it is a good idea to have a three step process. Step 1. Apply for patent pr...

As someone who works in the medical device industry, I can say that this course did a great job of covering most of the different aspects of the field...

I actually found a recent example of kickback allegations. The company is called Tenet Healthcare- a healthcare services company headquartered in Texa...

My company uses FMEA (Failure Modes Effects Analysis) for risk assessment. An FMEA is a step by step approach to identify all possible failures in a d...

I agree that is is important to analyze external factors! Once example I know is that IQ's (part of validation) are needed even if the product is move...

Hi Roberto, In addition to the points some people mentioned above, I believe there are some additional benefits to keeping meeting minutes: 1. They ...

In my R and D work experience, I worked a lot with new product development and just as our senior design projects, customer needs/design requirements ...

I believe it is important to directly quote the FDA about design inputs (ISO 13485:2003) Inputs relating to product requirements shall be determined ...

I think the following is a great way to think of verification vs validation: Validation: Are we building the right system? Verification: Are we buil...

Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic foc...