Having both design verification and validation as separate processes is necessary because they address fundamentally different questions in product development. Verification ensures that the design ou...

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many AI models have algorithms that can change after th...

I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sure the device gets the technical specifications dow...

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, sometimes more significantly than in other cases, it is...

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has...

That’s a great question — it’s true that design verification and validation (V&V) can seem redundant at times, especially when tests or documentation overlap. However, they serve distinct purposes...

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, a...

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each stage of the design process. Creating a medical devi...

I agree with everyone that design controls don’t have to kill creativity - it really depends on how teams use them. One idea I haven’t seen mentioned yet is how design controls can work alongside agil...

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to en...

Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn't pass regulation be rejected immediately, and the constraints would force for more unique...

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes feel overly focused on documentation rather than t...

I completely agree that GCP guidelines are done correctly in terms of safety and efficiency. GCP is extremely important in ensuring the validity of a medical device, drugs, etc. Protecting patients is...

While many GCP guidelines involve extensive documentation, I believe they are absolutely necessary to protect patients participating in clinical trials. These standards are the foundation for building...

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to ta...