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. Understanding organisational culture and structure helps decision-makers do the right thing. Those executives must…[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 on how probable is a given event. This probabilistic approach is applied to every factor that is analysed. The risk is the…[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 team assess project scope definition, identify risk elements, and subsequently…[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 criticism of any suggestion is permitted.
4.Any potential risk identified by anyone should…[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 820.3(aa) Verification means confirmation by examination and p…[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 the design transfer process:
* ensuring the device design–configuration
* Transfer…[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 could be a failure. Though tiring, it’s always preferred to go back and refer the document and then modify the…[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 and define responsibility for implementation. The plans…[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 refer to.

However, I was wondering if those of you in a medical device company, maintain these Design…[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 process of checking that something satisfies a certain criterion,”and verification can mean: “ad…[Read more]