Alternative dispute resolution (ADR) refers to techniques used to resolve conflicts without going to the courtroom. As healthcare and malpractice cost...
In January, the former owner and the former operator of a California durable medical equipment company were sentenced for paying physicians kickbacks ...
The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the healthcare system. Kickbacks – hidden financial arrang...
A key element in organization (and work units within an organization) success is its structure – how its work activities are organized; and how respon...
The way employees behave at work will differ from their behavior as individuals in a social setting. A variety of factors influence organizational beh...
I agree there will be an impact of culture on organizational Structure. Organisations can change with time. What was once a very informal office atmos...
Factor analysis of information risk (FAIR) is a taxonomy of the factors that contribute to risk and how they affect each other. FAIR underlines that r...
Risk Management Methods start with Risk Screening. Starting from categorizing them from High Impact and High probability, risks are analyzed using a n...
The risk identification process on a project is typically one of brainstorming, and the usual rules of brainstorming apply: 1.The full project team sh...
According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation mean...
Design transfer is an integral process in the early life of a product. It must be well executed, especially for complex medical devices. FDA's quality...
I understand how frustrating sometimes it can be to refer to a small parameter in these test documents or the product documents. But, when a product i...
Design Development Plan is the foremost important aspect in starting a medical device project. According to FDA regulations on Design & Developmen...
Design Inputs make up of higher level requirements, that trace to Design Outputs which is a more low-level specific requirement. One way to maintain t...
Validation and verification are frequently mentioned in tandem. They're often called V&V. To get a good understanding of this, I wanted to add a ...