Of all the phases involved in the product life cycle, as others have stated, the planning and development stage would seem to be the most expensive. ...

This is a very interesting topic to bring up. If the market does not seem appealing or in bad condition, then it would make sense for the company to ...

The product manager is in charge of a specific product being released and follows through the product’s life cycle. The product manager is in charge ...

This is a very interesting factor to point out. Validation deals more with the process of ensuring that the customer’s needs are met. Verification f...

In a situation like this, it is primarily important to determine the factor that caused the failure. Once the reason for failure is found, then measu...

Although I haven’t dealt with a validation process in a work place, the process is very important in determining the effectiveness of the product. Th...

It is good to be proactive and reactive for medical devices. Medical devices may sometimes be used externally, but other times they will be implanted...

It would seem a bit tedious to revalidate the equipment each time it is moved to a different location. However, it would be more beneficial to revali...

This is a very interesting point to bring up. As others have mentioned, revalidation is necessary when the product or device has been modified or upd...

The SOP documents are important in the process of Design Transfer in ensuring the device will be able to be created following a routine. All parts of...

When starting a medical device company, it is very important that the validation processes for the devices are followed. As others have mentioned, it...

It does seem a bit tedious to repeatedly update the document when a new revision is made because then multiple documents will have to be updated as we...

Both types of QMS are beneficial for a company to ensure the best quality products and work environment. The first type of QMS takes into considerati...

A written SOP can never be made to be too detailed. The SOP is written as a descriptive document containing instructions on how to create a specific ...

The Standard Operating Procedures (SOP) is a very important document that is needed in describing the procedures needed to complete the making of a pr...