In the Discovery and Innovation phase of the Product Life cycle phase, it is important to understand the customer. Analyze and research the customers needs, if there is something that could fulfill a ...

As others have mentioned the main reason a product gets "killed" midway through the research phase is simply due to the money. If the research and development of the device is taking too long and uppe...

I don't have experience with dealing with a launched product that failed, but the most recent example of a product having to be pulled from the market are the Samsung Note 7s. This massive recall was ...

The purpose of the SOP is to create a step by step procedure to help workers carry out routine operations. So, I don't believe that there is any issue with having too much detail. The purpose of this ...

I believe SOPs are required for the research phase, because there should be steps on the thought process of you reaching that idea, exploring the different possibilities, creating different designs, a...

As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the validation depends on what type of medical device you...

I don't believe there is really an expiration date for a validation. Each installation qualification process gets updated every year or so. Due to this, it accounts for any changes that may occur in t...

Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and information on how the regulations for the EU works...

Along with having multiple vendors, as a Manager you should also account for the risks that a potential vendor may run into issues. With this you schedule and plan dates for either an early finish, wh...

In my current work place, the type of validation that we have preformed is the Prospective Validation which occurred before the product was released to market and the product was not fully ready to be...

If equipment gets moved from one location to another, I do agree that a revalidation would have to occur, but for only certain aspects. There are many validation processes, so I don't believe a full r...

For the antibiotic releasing hip stem manufacturing line which creates an artificial hip with an antibiotic coating on the surface, I believe the IQ involved in this manufacturing line would be writte...

ECO's are not very commonly used once the device is on market due to the main reason of money. However, recently at my company the on market device which is used globally and in specifically in China,...

Per personal experience to track the medical devices while it is on market, the company I work at has a technical support team that answers any immediate questions or complaints a user may have. Hopef...

To answer your question of when do you need to generate a DHF vs. DHR is that the DHF is created during the first planning session of the developing the device. This includes every document from the i...