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. During this stage in the product life cycle, the c...

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 decide to stop production. However, this could al...

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 of making sure the product is successfully built a...

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 focuses on making sure that the parts involved in c...

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 measures can be taken to fix the issue and possibly pre...

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. There are different types of validation methods; one...

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. From a business standpoint it would be more ben...

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 revalidate the equipment every time. Although the new l...

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 updated from the original design. However, if there ...

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 the SOP play a significant role in the document. ...

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

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 well. However, I do feel that it is very important ...

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 consideration the general quality measure by including a qual...

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 product. The more details written in the document...

The Standard Operating Procedures (SOP) is a very important document that is needed in describing the procedures needed to complete the making of a product and the steps involved. With the SOP, a set...