I believe comparing the two documents and ranking them in terms of more usefulness might not be the best because the DHF is used widely by the FDA and Technical File and Medical Device (MDD) are for t...

The company the I work for uses a similar document that you stated. Using an excel spreadsheet with necessary columns to fulfill. I believe the method or specific document used can be irrelevant if th...

The one big difference in classification I see between the FDA and the EMA is the class II classification. In the US, around 25 percent of the class II devices do not go through a clinical trial, wher...

I believe the Guidance MEDDEVs is an important guideline. First and foremost they are drafted by the proper authorities that are in charge of being a safeguard for the public health, and guidelines th...

There are big differences between the Design History File, 510k Submission, and the Technical File. The design history file is an FDA regulation that talks about the design controls and the changes an...

When it comes to business then verbal contracts should never be considered. Fighting this in court is very difficult when it turned into a he said/she said. One way to prove is the proof expenses and ...

I do not think this is an over-restriction. These types of restriction are needed to keep the overall benefits in mind, instead of doctors being influenced by gift. The gift can easily be seen as brib...

An NDA is a contract of confidentiality, where a patent is a protection of intellectual property. Contracts are enforced differently in various states and very much matter solely on how well it is wri...

Corporate culture represents the professional values a company adopts that dictate how it interacts with employees, vendors, partners and clients. An effect organization in a corporation can lead to a...

As a project manager, I believe a matrix organizational style would be the hardest or a more involved method to execute. The first aspect that makes this a more difficult organization is the presence...

Depending on the size of the company, its resources and number of projects the company holds can influence the best type of organizational method. For smaller businesses a project bases organizational...

I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in it...

I also agree with the 4th example being a very important aspect of risk management. When a company conducts it own identification of risks and test they try to be very thorough. However, a company can...

The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed...

I have not been part of designs review in industry. However, last year a group of BME students and I applied for a URI grant and wanted to start our own project. We had design review meeting for each ...