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 cop...

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 Fi...

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 s...

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...

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 de...

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 ...

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. Ba...

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 backgro...

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 an...

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 likely that ...

The consultant does violate the NDA or CDA by copying the template from the previous company. Each company should follow their own template when completing contracts. Although companies are similar ...

When signing an NDA there are many factors to consider before accepting the contract. As mentioned above, it is very important to pay attention to what is written in the agreement and the time period...

When determining which organizational structure is best for a company, it is important to take the company’s size into consideration. The organizational structure essentially determines the communica...

It is healthy to have a little competition within a company, especially when it is friendly competition. However, if it becomes more than that, it can result in hurting the company’s work and its suc...

When two or more companies come together and decide on collaborating on a project, it is very important that the project is ran smoothly. There are issues that arise within a company when working on...