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 patent, applying for this…   Read more»

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 excellent…   Read more»

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 undocumented Hispanic women to Tenet hospitals, which charged Medicaid for deliveries. The hospitals…   Read more»

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 product or service. Failure modes are…   Read more»

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 you have to consider…   Read more»

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. They drive action. 4. They act as a…   Read more»

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 customer told us their needs (in my…   Read more»

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: a) functional, performance, and safety requirements, according to the intended…   Read more»

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 is concerned with checking that the system will…   Read more»

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 product design and that what is produced consistently…   Read more»