Definitely great points made, but with the DHF even though it contains all revisions, changes, and mistakes from the devices inception it will also contain design input requirements and user requireme...

By process, I am assuming you mean any standard operating procedures and policies created by the Quality department. These processes are considered higher level documents, which explain how to perform...

The school of thought that appeals to me the most, is the process where once the design transfer occurs the DHF is sealed. I say this mainly because I only have experience doing it this way. After the...

I believe the main difference is that the EU focuses on the risk as Dr. Simon mentioned in his lecture. Each classification based on the medical device directive is based on risk, so to an extent, the...

I do not have experience with filing for combination products within the EU but I believe what helps in distinguishing if your product falls under the MDD 93/42/EEC or the MDP 2001/83/EEC is to choose...

Per my personal experience, the current company I worked for used the same approach in receiving approval by the EU and obtaining the CE Mark before getting FDA approval. In general I believe it was e...

Outlined by the FDA if it is difficult or unclear on determining the primary mode of action for the combination product, you can file a Request For Designation (RFD), which is outlined in 21 CFR Part ...

In dealing with contracts, one issue that sometimes comes up especially when working with a company that is overseas is pay of currency. Contracts were written the amount that they would be paid in US...

I currently work in Industry, and with the new age of technology the point of care diagnostic device that I work on added a new capability of connecting wirelessly with being able to transmit collecte...

I believe the medical device development course was a great way to give exposure to the industry side of things. I think classes similar to this give the best real life experience in the work field be...

The difference is that a patent is a federal document proving ownership of an idea, and an NDA is simply a contract between two people. So in other words NDA’s only recognize the signatures on the con...

As others have mentioned a written contract is a legal binding document, where you have signed pen to paper. Certain clauses allows to you to break from it, but if you there are any agreements in the ...

In a company setting, working with someone you have a good relationship with always does helps tasks move faster to get things done, but I do not believe you should look away at an individual who may ...

I believe, if first starting up a company, such as a start up and do not want to have the corporate feel to the company, I believe an organic organization structure makes the most sense to start off. ...

In my current company, the organization type is a mix between functional and a project based organization. There are individual departments ranging from Hardware Eng, Quality, Software Eng, Systems En...