Alternative dispute resolution (ADR) refers to techniques used to resolve conflicts without going to the courtroom. As healthcare and malpractice costs continue to rise, there is growing interest in tactics such as early apology, mediation, and arbitration in the medical…   Read more»

In January, the former owner and the former operator of a California durable medical equipment company were sentenced for paying physicians kickbacks for patient referrals and prescriptions for unnecessary equipment — primarily power wheelchairs — which were used to support…   Read more»

The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the healthcare system. Kickbacks – hidden financial arrangements between doctors and hospitals or other healthcare providers or companies – are one of the most complicated…   Read more»

A key element in organization (and work units within an organization) success is its structure – how its work activities are organized; and how responsibility and authority are identified. Structure affects how employees – even at the very top of…   Read more»

The way employees behave at work will differ from their behavior as individuals in a social setting. A variety of factors influence organizational behavior, including the company’s structure, policies and procedures, management effectiveness and interactions between colleagues. All of these…   Read more»

I agree there will be an impact of culture on organizational Structure. Organisations can change with time. What was once a very informal office atmosphere may have to become more formal as the size and scope of the business expands….   Read more»

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 risk is an uncertain event and one should not focus on what is possible, but…   Read more»

Risk Management Methods start with Risk Screening. Starting from categorizing them from High Impact and High probability, risks are analyzed using a number of methods. The PDRI(Project Definition Rating Index) is used in front-end project planning to help the project…   Read more»

The risk identification process on a project is typically one of brainstorming, and the usual rules of brainstorming apply: 1.The full project team should be actively involved. 2.Potential risks should be identified by all members of the project team. 3.No…   Read more»

According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation means establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled and…   Read more»

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 system regulation requires the manufacturer to complete the following steps in order to satisfactorily complete…   Read more»

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 is not functioning to it’s ability, one factor could one or more specifications listed…   Read more»

Design Development Plan is the foremost important aspect in starting a medical device project. According to FDA regulations on Design & Development Planning (820.30(b)), “Each manufacturer shall establish and maintain plans that describe or reference the design and development activities…   Read more»

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 their inputs is the Design Input Document, that is maintained in the DHF, which Quality can…   Read more»

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 few points that would explain the difference a little better.The literal meaning of validation means “the…   Read more»