In agreement with the post above that it is more beneficial to be proactive than reactive. In the reactive approach, a root cause analysis is usually performed to answer ‘why’ a problem exists. However, with the proactive approach, different kinds of corrective actions will prevent the ‘why’ from happening again. We are usually more likely to…[Read more]

I agree with the post above that it can be tedious and time consuming to re-validate all processes. However, the process is very critical to make sure that the equipment is producing the same results in each location. If the equipment is being assembled in different location then the results can vary due to errors. Instead of re-validating each…[Read more]

I worked in the software development area. Our company would call it the Engineering Change Order for Code Change. There were many change orders depending on whether it was an addition to the code, or enhancement. Sometimes, it would be required to process a change order for even maintenance especially if it would be server maintenance. I remember…[Read more]

The change process is really when someone identifies an issue that may need to be addressed. In agreement to the post above, there is a cost factor added to any kind of ECO. Therefore, an ECO is reviewed very carefully before signing off since there are many factors attached to it. I worked in the software development side and our client need some…[Read more]

SOP is basically a step by step instructions document compiled so that the workers can carry out a complex routine efficiently. I definitely think the SOP’s should be written during research phase. In fact, I used to intern at a lab where we were researching on stem cells. Obviously, the very first time if you are running a procedure it will have…[Read more]

A follow-up question from Dr. Simon’s post:

As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more logical to me.

For those of you who are currently working in the medical device industry or have had previous experience with this, which of those two thoughts does your company follow? Is one…[Read more]

The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the 510k submission. A technical file is very similar version to a DHF except that is a European version for the 510k. The technical file…[Read more]

In my opinion, the first thought where the DHF is sealed and any updates after the design transfer are added to the DMR seems more logical. Technically, DHF is put together initially when the product was being planned, researched and prototyping it. Once the design is transferred, then any change needed to the product goes through a process and…[Read more]

I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is classified as a Class III device in the US where as in the EU it is classified as Class II. This is surprising since there have been many petitions to classify female condoms as Class II, similar to…[Read more]

Another difference between 510k and a technical file is the submission of a clinical evaluation report. All devices with a CE marking must have a clinical evaluation report. It is an essential requirement in Annex I of the Medical Device Directive. It is surprising to know that even Class I devices need to submit a clinical evaluation report.…[Read more]

One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be submitted regardless of where the medical device is being sold. The US FDA doesn’t require a risk management file as part of the 510k submission. The US FDA only requires it if the device contains a…[Read more]

I used to work for an IT firm where I was assigned to a client that used to focus on VR for physical rehabilitation. Earlier, that company was hiring their own technology experts/consultants to provide the technology. Over the course, they chose to contract the work out. Therefore, they gave the contract to my company for the software development,…[Read more]

I have not had an experience working with PMOA for a combination device yet. Upon some researching, I have found out that PMOA is very critical when establishing a product’s regulatory and product development framework. Technically speaking when we need to identify the function of a product, we look at what the product does and where is the…[Read more]

In my personal experience, I also had to sign a non-compete during on boarding which restricts me from working at certain companies. I have witnessed cases where my client wanted to hire an employee where we had a non-compete with. In many cases if the client and upper management come to agreeable terms and then it is possible. Although, these…[Read more]

NDA usually excludes the information that is publicly available or information that was already made available to the recipient prior to its disclosure. It also excludes information which was obtained by a third party which may or may not be under another confidentiality obligation. It is very important to narrow the scope of information to…[Read more]

Although, the team members enjoy working with people who they have a good rapport with. However, in my experience roles are allocated in a team based on a team member’s expertise and background. There are always few subject matter experts depending on the scale of the project. Rest of the team may not have any experience with the matter before.…[Read more]

I too have been a part of a Matrix organization. I would agree with the posts above that it does get confusing sometimes. I had a functional manager and a reporting manager for the same project. However, the things were made very clear to me in the beginning of what the purpose is of both the managers. I would report to the functional manager on…[Read more]

Delegation is one of the key differences between upper and middle management. Since a senior manager spends most of his energy on creating effective strategies. He has to be able to delegate decision making on non-strategic issues. In order for this to happen, a manager needs to realize the strengths and weakness of his team to delegate properly.…[Read more]