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 protection If your invention can be protected by a p...

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. We learned a wide range of topics which give an ...

I actually found a recent example of kickback allegations. The company is called Tenet Healthcare- a healthcare services company headquartered in Texas. The prenatal clinics allegedly referred undocum...

What factors contribute to determining values for risk index numbers. Two examples are 'how often the failure occurs'? and 'what is the severity of the failure?'.

How would a company use risk index numbers/values to determine sample size for protocols (e.g. validation)? If you are in industry- perhaps you can give examples of what occurs in your companies? For...

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 design, a manufacturing or assembly process, or a p...

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 moved one foot on the product assembly line because yo...

Hi Roberto, In addition to the points some people mentioned above, I believe there are some additional benefits to keeping meeting minutes: 1. They offer legal protection. 2. They provide structure. 3...

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 and test plans are huge deliverables. Once the cus...

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

I think the following is a great way to think of verification vs validation: Validation: Are we building the right system? Verification: Are we building the system right? In other words, validation i...

Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective produ...