Last seen: Dec 1, 2025
Verbal agreements still play a role in early conversations, but they’re best viewed as relationship-building tools rather than anything that should ca...
NDAs in the medical device and biotech space are often used more aggressively than truly necessary, largely because companies operate in an environmen...
Several high-profile scandals in the 1990s and 2000s directly shaped today’s AdvaMed and DOJ-enforced compliance rules, most notably the 2007 orthoped...
FMEA is useful, but it can create a false sense of completeness because it treats failures as isolated, linear events, while real-world medical-device...
In medical devices, the goal can never realistically be zero risk, because every design choice—materials, power sources, software, biocompatibility, b...
Risk controls go too far when the new complexity, failure modes, and human-factor burdens they introduce outweigh the risk they were meant to reduce; ...
Organizations can balance the need for up-to-date documentation with efficiency by adopting a structured, tiered approach to document management. Core...
The best way to translate a qualitative user need into a quantitative and testable design input is through iterative analysis and measurable criteria ...
While modern design control systems like ISO 13485, IEC 62304, and FDA 21 CFR 820 are far stronger than those in the Therac-25 era—mandating rigorous ...
The best way to translate a qualitative user need into a quantitative and testable design input is to follow an iterative process of user analysis, me...
In practice, successful design teams balance user needs and business realities through structured trade-offs rather than choosing one side completely....
Having both design verification and validation as separate processes is necessary because they address fundamentally different questions in product de...
While design controls under regulations like ISO 13485 and FDA 21 CFR 820 can feel restrictive, they actually play a dual role in innovation. On one h...
Both the placebo and nocebo effects provide valuable insight into how psychological factors influence physiological outcomes in clinical research. I f...