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 company is constantly working to make their product unique and fix any issues that arise. This is more cost into developing the product. The product…[Read more]

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 also, hurt them as well. Many times it may seem that there is no more need for the product, but when it goes on the market it may be very successful.…[Read more]

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 and launched into the market. As others have stated, all the responsibilities of the product manager is important. It is very important that the p…[Read more]

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 creating the product are correct. The validation process is more intense and requires more moneywise and regarding time. The verification process, h…[Read more]

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 prevent the failure from occurring again. After the machine is repaired or a new machine is installed, the maintenance and calibration schedule might…[Read more]

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 type being retrospective validation. Retrospective validation is used for established processes. This form of validation cannot be used when a m…[Read more]

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 beneficial for a company to be proactive when it comes to medical devices. This will ensure a safer device. As a result of medical devices being used…[Read more]

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 location may reflect the same environment conditions as the original, the equipment should be revalidated to make sure the same results will be given.…[Read more]

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 are no changes and the device is functional, then there is no need for revalidation of the product. However, the original validation would make…[Read more]

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. I agree with you that the procedures are important because they ensure that the purpose is fulfilled. Also, the procedure includes the steps…[Read more]

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 that the needs of the customer are met. There are specific regulations to follow according to the FDA for validation processes to ensure the best…[Read more]

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 and necessary that this process is done. If the revised document is not recorded, then the current documents will not be suitable for the revision.…[Read more]

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 quality manual, quality procedures, and records. The second QMS seems to be the more effective approach. With the second method, the work instructions…[Read more]

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 better off the product will be made. It may seem tedious to write so much information, but it is beneficial to the company. The more details…[Read more]

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 method is placed within to the company as to how to create a certain product. During the research phase, it is essential to take into consideration…[Read more]

Of the two processes involved in the logging of changes made to the DHF, the second one seems better. When changes are being made to the product, even after the Design transfer, there should be a copy in the DHF noting these changes. Any change made to the design is important, no matter how small it may seem. As a result, there should be a…[Read more]

When comparing both types of documents, the DHF document would seem more useful than the Tech File / Design Dossier. The DHF file gives an overall informative description of the product. The Tech File / Design Dossier document just gives a generic idea of what the product will consist of. The DHF document takes in to consideration all the…[Read more]

The Validation or Verification test report is very significant in determining the success of a product. Once the Validation or Verification fails, it is important to go through the protocol step by step to find the factor that caused the failure. Although this may seem to be time consuming and waste in money, this would be the best process in…[Read more]

In the US, the approvals for medical devices are done by the FDA. The FDA approves the device for the whole country, and has the ability to inspect and audit. In addition, they have the authority to take products off the market and even shut down companies if they find necessary. As a result, in the US, it is very difficult in getting the…[Read more]

The classification of a device is determined by the risk of the device. If the device in question for classification has a higher risk, it is likely to have a higher classification. However, many device classifications differ between the EU and US. For example, the device class for the urinary catheter is not the same in both areas. A urinary…[Read more]