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, eve...
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 in...
The Validation or Verification test report is very significant in determining the success of a product. Once the Validation or Verification fails, it...
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 a...
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 ...
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 Compet...
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 analyzi...
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 pop...
The fifth P of marketing, participation plays a very important role in making an effective marketing strategy. With participation, the company promot...
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 amo...
The consultant does violate the NDA or CDA by copying the template from the previous company. Each company should follow their own template when comp...
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 wh...
When determining which organizational structure is best for a company, it is important to take the company’s size into consideration. The organizatio...
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 ca...
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 ...