You bring up a great point about validation—it’s all about making sure processes can reliably produce a product that meets specific standards. Defining clear success criteria upfront is key; without it, goals can shift, which wastes time, resources, and can…   Read more»

You’ve nailed an important point about design controls—they’re all about making sure a medical device is safe and effective by following a structured process. By having these controls in place, manufacturers can catch potential issues early, which helps avoid expensive…   Read more»

Design control is a sensitive and important task in medical device manufacturing companies. The protocol to undergo design control and review can be considered a milestone in meeting regulatory norms and standards. This helps with product failure, rejection, mall function,…   Read more»

Enhanced Data Security and Patient Privacy:  Likewise FDA, medical companies have to follow HIPAA regulations. If the device is connected to a software operation, software validation protects the patient’s sensitive and personal information. Software validation and authentication guards prevent patients’…   Read more»

Medical device manufacturing companies have more crucial and sensitive responsibilities than other corporate sectors. Medical devices have a direct impact on the health and wellness of society. Despite medical companies abiding by FDA or ISO standards, new or small companies…   Read more»

As someone who works in a research field the project proposals created in my field may be different as our work tends to also focus on  publications and research based goals. Overall they tend to formulate in similar ways. Background…   Read more»

At work I have implemented the use of meeting minutes as a way to highlight project progress and highlight team member achievements. In the minute  meetings we all highlight the main progress in our projects which can then be easily…   Read more»

In industry, I had experience with method validation and verification as part of the work I did on our machines. The main differences between the two is mainly how validation involves ensuring that the product meets our customers’ or laboratory’s…   Read more»

There are many factors that go into deciding how to interpret these guidelines. A few that I can think of include Regulatory Strategy and Risk Tolerance, and Experience with Regulatory Audits. In terms of regulatory strategy and risk tolerance, some…   Read more»

I think that the steps taken to define success criteria have been more or less clearly represented by previous responses in this discussion thread. I’d like to expand more on the disadvantages of moving target success criteria. For one thing, moving…   Read more»

A few more benefits of software validation include but are not limited to:Extended Device Longevity and Lower Maintenance Costs: Validated software is typically more stable and less prone to bugs or malfunctions, reducing the need for frequent updates and repairs….   Read more»

In the context of design control, it is indeed common for companies to have a Design Input Document (DID) while not all have a corresponding Design Output Document (DOD). This discrepancy happens in scenarios where the design inputs are clearly…   Read more»

Two other benefits of software validation include: Enhanced Regulatory Compliance: In industries such as healthcare and aerospace, software validation ensures that the device software meets the strict regulatory standards throughout its lifecycle. By adhering to these regulations, companies can facilitate…   Read more»

In my experience, the validation processes of testing and verification are essential for enhancing the quality and success of product development across various industries. These processes help detect errors early, minimize the costs associated with fixing defects, and improve product…   Read more»

I think these four columns give a solid starting point, but adding a few more could definitely enhance the matrix. A ‘Timeline’ or ‘Deadlines’ column, for example, could help keep track of when each design phase is expected to be…   Read more»

My capstone project focused on using machine learning to detect defects in roll bearings. We trained models on a variety of datasets to identify early signs of bearing wear and tear. One challenge we faced was balancing model complexity with…   Read more»

Totally agree on how industry deadlines can limit the number of inputs! From my own experience in school projects, we had to prioritize essential features to keep on schedule. In a real industry setting, I imagine it’s even more pressing,…   Read more»

I think it is very possible for teams to log additional design inputs beyond the basic requirements, especially when trying to anticipate factors impacting long-term performance, regulatory shifts, or future iterations. Over-engineered design controls are meant to prepare a product…   Read more»

When creating test methods and protocols, key factors include ensuring that the tests accurately simulate the device’s real-world use, assessing risk to patient safety, regulatory compliance, and repeatability. Each test should align with critical design inputs, measure the appropriate performance…   Read more»

Design controls are critical to mitigating potential risks in product development. They guide the design process to make sure a medical device meets safety and performance requirements. By establishing clear design inputs, conducting risk assessments, and performing verification and validation…   Read more»