I had completed my undergraduate degree at NJIT and remember creating the requirements document and the test plan. I remember how detail oriented, yet concise those documents had to be and being so frustrated when completing them. As my advisor…   Read more»

I’ve participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so I was questioned on some things but was able to adequately clarify everything. Some of the…   Read more»

Design control is a systematic process with a range of activities that will guarantee the product development and meets the regulation requirements with a number of key elements. It is about planning, design execution, testing against the specifications and requirements,…   Read more»

I’ve done and am actually in the middle of a shelf life validation for raw materials and final device. We’ve included in it packaging, transportation, and storage studies in accelerated and real-time aging. In the past, I’ve done software validations…   Read more»

They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood typing machines, aren’t chemical compounds made to react a certain way in the…   Read more»

Design Controls are a set of quality practices and procedures Control the design process to assure that the the device meets: User needs, Intended uses, Specified requirements They can improve and prevent future issues. Design controls apply to: – All…   Read more»

I agree that one way to keep the DHF audit ready is to ensure the document is “living” and accurate to the product currently being produced. Although, I would like to bring up some of the risks associated when auditing…   Read more»

In medical devices, validation is generally important to make ensure that the intended usages of a device are safe, if there is an update or change has been added to the device, and a clinical trial is required. So, I…   Read more»

My closest experience working with design controls was when I developed a surgical stapler testing apparatus for my undergraduate senior year capstone project. My team and I implemented the twelve-step engineering design process to effectively develop our idea from concept…   Read more»

I agree with some of my classmates’ opinions, I don’t think I would say one part of the DDP is more important than the other. All the information provided in the DDP provides a well-established foundation to execute the project….   Read more»

Minutes for meetings are extremely important. It helps to make sure the agenda of the meeting is completed within a certain time. Also, documenting these minutes is also useful when there is an inspection regarding the project. It helps to…   Read more»

This is an interesting question. I would say DDP as a whole is important for a project to work in a precise manner. But the most important this amongst the DDP I would say is the Gantt chart. The Gantt…   Read more»

It is hard to say which part is important from the DDP. DDP is everything that the project has. But if I had to choose it would be the Gantt chart as it has all the schedule i.e, the timeline…   Read more»

Interesting posts. I agree with many of you in regards to the importance to diligent record keeping and constant updating the DHF. It is in fact a “living document” as it was pointed before and will need continuous upkeep to…   Read more»

I have not been in any kind of company meetings as I am not working right now but last week I was in a meeting with the project group of Medical Device Development. The project manager has sent out the…   Read more»

I have also used reliability and confidence to determine sample sizes for testing during validations. I have also used AQL (acceptable quality limits) sampling when doing additional testing to mitigate risks observed with processed non conforming products. We also use…   Read more»

All plans of the DDP could be considered important as they each serve their own purpose. Without one section, the entire project can fall apart. I believe it also comes down to having a good balance of everything. If each…   Read more»

Each part of the Design Development Plan has its own importance however the scope management plan is especially important because it sets boundaries for the project. A project can have excellent communication and quality protocols however without a strong grasp…   Read more»

Like others have stated, it is imperative to track all changes that have been made to a product. At bare minimum, it provides a history of everything that was altered with a product and can be referenced back too if…   Read more»

As pointed out by Dr. Simon if a medical device is a component and not directly used by the patient then the user needs and the specifications are essentially the same thing and design validation is not necessary for that…   Read more»