One critical aspect of design controls that deserves further emphasis is the integration of risk management throughout the product development lifecycle. Risk management is not merely a regulatory checkbox; it is an essential framework that enhances product safety and effectiveness….   Read more»

Software validation is a great feature that can help in many ways. One big help is in customer satisfaction, if the software for a product works as expected and outputs the required information, less time will have to be spent…   Read more»

As mentioned in the lecture, some companies do not take Design Control seriously, and instead create these documents as an afterthought, and just fit the already created methods into the required formats. This can lead to major problems downstream. For…   Read more»

While it is certainly possible to overdue it, I think logging more inputs then you think you will need is a smarter way to go then just logging the bare minimum. If failures start to occur in the device and…   Read more»

Design control does exactly that, control the design. This helps potential risk by keeping a track of how the design of the product can keep in line and not stray. It also helps with how to troubleshoot potential problems in…   Read more»

I find that over-validation does occur in many instances, but there should be a balance of wanting to do better and over-validation. Each company should have a baseline of what the company is expected to do, but I also believe…   Read more»

I find that the DHF can be a bit overwhelming, the best way I can think of structuring it is like a lab report. You have your sections that you need but you always start with one part, for me…   Read more»

Hi la82,You are right design control is an integral part of product development, but issues can arise if it’s poorly managed. Without proper design control, specific requirements can be overlooked, which may lead to safety risks or issues when trying…   Read more»

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification might already outline the outputs. In some cases, the device output might not be available until after…   Read more»

Hi sumayia-chowdhury,Design control teams mitigates risk by implementing a structured, step-by-step process throughout the development of a product. By setting clear requirements, conducting reviews, and performing tests to verify a products ability, they can confirm that the design meets user…   Read more»

It is possible that teams log additional design inputs beyond the requirements for different reasons, including predictive measures, future risk prevention, or preparing for later iterations of the product. The goal is typically to meet the essential inputs for verification…   Read more»

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory approval, and market access.  If the software is used in a hospital to store patient data, and track their medical history,…   Read more»

Hi hodafattel,You are right in saying that inputs usually have outputs, but not always directly. For instance, a DID might specify user needs like “easy to use” or “durable,” which aren’t standalone outputs but guide multiple outputs . In these…   Read more»

A DHF can become overwhelming if not managed correctly. Some ways to mitigate this are to organize the DHF by development phase to make it easy for any reader to follow the development process, group together similar types of documents…   Read more»

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Design Verification, which only checks if the Design specifications are met. In a case where…   Read more»

Validation processes such as testing and verification are if utmost importance to product development across all industries. In my experience, these processes play a crucial role in identifying defects early, confirming the product meets user requirements, and building confidence in…   Read more»

I agree with others comments. I believe that two additional long-term benefits of software validation that positively impact a device with software over its life cycle are:Improved Regulatory Compliance: Validated software ensures that the device meets regulatory standards from the…   Read more»

I agree with you. I believe that design controls are essential quality practices applied in the medical device design and development process to ensure that devices are safe and effective for their intended use. This structured approach covers planning, design…   Read more»

To manage a large DHF effectively, break it down into modular sections aligned with design phases and use a detailed, hyperlinked table of contents. Maintain document control through a versioned management system, keeping only current documents in the DHF and…   Read more»

Design control is indeed a big help to mitigate risks in medical device development. It is basically the framework of standards and tests required for the development of such project to ensure it meets all the requirement to eventually get…   Read more»