The key to determining whether a risk is truly worthwhile lies in evaluating how integral that risk is to the product's intended use. However, it is c...

I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like...

I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participan...

An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices ...

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I rea...

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are view...

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production proc...

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification a...

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other...

Based on the responses thus far, transparency, bias, and privacy seem to be the three most critical and identified ethical challenges for using AI. I ...

Virtual trials and telemedicine have certainly bolstered the inclusivity of recruitment, but another promising development is the use of real-world da...

I agree that patient safety and data integrity are critical to ethical clinical research, and the principles of ICH-GCP certainly operationalize such ...

Zoom is a company experiencing rapid growth due to its optimization of telehealth and virtual care. Despite Zoom being originally a video conference p...

AI can certainly transform medical device marketing, particularly when it comes to understanding audience behavior and personalizing outreach. However...

I certainly agree that patient perspectives greatly add value to marketing strategies, particularly as patients are increasingly seen as partners in t...