Despite having the same objective of evaluating safety and efficacy, drug and medical device studies differ widely in terms of their focus, objectives, and structure. The methodology used in drug trials is linear and phase-based, with each stage building on…   Read more»

Multi-center trials definitely bring unique challenges, especially around maintaining consistency across sites. I agree that clear communication and standardized protocols are key here. Regular training and centralized data management can help keep everyone aligned and ensure that data quality stays…   Read more»

Patient safety and data integrity are at the heart of clinical trials, and guidelines like ICH and GCP provide a framework to ensure both. These standards emphasize rigorous protocols, informed consent, and careful documentation, safeguarding participants and maintaining reliable data….   Read more»

Though I don’t have industry work experience, from my understanding- verification ensures that a product is constructed accurately and accordingly with its design requirements. To verify compliance with the standards, laws, and physical characteristics specified in the design documents, testing,…   Read more»

Patient recruitment is a big hurdle in clinical trials, often causing delays and impacting study timelines. CRAs and CROs tackle this by using diverse strategies, like reaching out through local healthcare providers, leveraging digital campaigns, and using data to identify…   Read more»

Great point! It makes sense that every design input should ideally have a corresponding output. Inputs set the foundation—they’re the requirements a device has to meet. In a perfect world, each input would lead to a specific output showing how…   Read more»

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»