Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and information on how the regulations for the EU works. With the EU they have 3 major…   Read more»

Along with having multiple vendors, as a Manager you should also account for the risks that a potential vendor may run into issues. With this you schedule and plan dates for either an early finish, which is the date for…   Read more»

If equipment gets moved from one location to another, I do agree that a revalidation would have to occur, but for only certain aspects. There are many validation processes, so I don’t believe a full re-validation would have to occur….   Read more»

For the antibiotic releasing hip stem manufacturing line which creates an artificial hip with an antibiotic coating on the surface, I believe the IQ involved in this manufacturing line would be written procedures on how to use the equipment to…   Read more»

ECO’s are not very commonly used once the device is on market due to the main reason of money. However, recently at my company the on market device which is used globally and in specifically in China, the main board…   Read more»

Per personal experience to track the medical devices while it is on market, the company I work at has a technical support team that answers any immediate questions or complaints a user may have. Hopefully most of the time the…   Read more»

To answer your question of when do you need to generate a DHF vs. DHR is that the DHF is created during the first planning session of the developing the device. This includes every document from the inception of the…   Read more»

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 requirement specifications. This essentially gives an overview of the device…   Read more»

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 a Design Validation Process, Product Risk Management Plan, Design Verification…   Read more»

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 design transfer,…   Read more»

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 EU is taking…   Read more»

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 a Notified Body with the…   Read more»

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 easier because the device that…   Read more»

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 3, and the specific…   Read more»

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 dollars, but sometimes the company…   Read more»

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 collected data up to a cloud….   Read more»

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 because they are actually…   Read more»

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 contract, whereas patents provide…   Read more»

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 contract that you…   Read more»

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 be more competent…   Read more»