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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»

All three documents are important in their own way in ensuring the safety of medical devices. As a result of the MEDDEV Guidance Documents and Competent Authority Guidance Documents being written by the Competent Authorities, they do not have the…   Read more»

I have not had any experience in defining the Primary Mode of Action (PMOA) for a combination device. The best way to define the device is by analyzing the two components involved in the product. Based on this, it will…   Read more»

There are many factors to consider when using the multi-center form of clinical study. With this type of study, there could be variations between populations in their genetic makeup, cultural backgrounds, and environmental settings. This could affect comparison of results…   Read more»

The fifth P of marketing, participation plays a very important role in making an effective marketing strategy. With participation, the company promotes a stronger interaction between the employees and customers. As mentioned in the lecture, participation gives the customer control….   Read more»

It is important that there is a restriction placed on the amount a company put into giving a gift to a physician. If there is no limit set on the amount of money a gift can be then it is…   Read more»