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. In this example of relocating the equipment, I believe it would be necessary to revalidate sterility, humidity, and…[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 manufacture the artificial hip. As well as contain calibration/maintenance schedules to make sure the…[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 of the device was not RoHS compliant. This required a massive ECO to change the material or add a protective layering to the main…[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 issue is not serious and is resolved by technical support but the complaint is still logged. However, if the issue is a bit…[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 device to the design transfer phase of the device. The DHF is more in depth of what document it contains, whereas the DHR contains a…[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 similar to the technical file. I believe though in the end the DHF would be more…[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 Procedure, etc. Specifically for a design verification procedure, it…[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, any changes to any design specifications, or software updates must undergo a Design Change Process (DCP). In this it details the…[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 notice of the potential dangers of the device. However, I believe most device companies would provide the research of showing the…[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 experience in assessing combination products. Also if you are a company from outisde the EU, help can also be provided by…[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 my company is working is a Point of Care Diagnostic Testing device which would fall under the IVD Directive 98/79/EC…[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 information to be included in the RFD is described in detail in 21 CFR 3.7. With this the FDA determines the combination…[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 information to be included in the RFD is described in detail in 21 CFR 3.7. With this the FDA determines the combination…[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 would want it written in their currency, such as Euros or Yen. That was a minor discrepancy that occurred from…[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. This includes storing patient information along with their test results, operator information, cartridge lists, etc.…[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 applicable. You are definitely more prepared for the real world after taking this course. Also, as someone who is currently…[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 proof that you own the idea entirely. So, if you sign an idea with a coworker, and develop this product, but then t…[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 proof that you own the idea entirely. So, if you sign an idea with a coworker, and develop this product, but then t…[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 proof that you own the idea entirely. So, if you sign an idea with a coworker, and develop this product, but then t…[Read more]