Emotional intelligence is quite crucial to the path to success. However, schools and training facilities focus more on cognitive abilities and academic access due to the traditional path implemented f...

Employees with different specialties are involved at each stage of the PDCA cycle. The plan and the do stage often consists of engineers, scientists, and regulatory affairs specialists who create and ...

Some topics that are unique to the biomedical industry are risk management in clinical trials and regulatory compliance. Biomedical industries often involve clinical trials that require managing the r...

I have not experienced gift-giving in the corporate world; however, there should be some set rules and expectations when it comes to giving gifts. When giving gifts, the company should keep the gifts ...

International contract law should provide uniformity and consistency across all countries so that there is an even playing field. Moreover, the contract should have a standardized dispute-resolution m...

To add to the comments made earlier, a confidential agreement (in addition to the basic components of the contract) should first clearly define what constitutes the document to be confidential and it ...

Given that the groups had already been assigned their specialty, such as marketing, pre-clinical research, clinical research, etc., the groups have taken on the structure of a functional organization ...

The shift from an in-person environment to a virtual environment definitely had a huge impact on the workforce. For functional organizations, the shift may have impacted maintaining that traditional h...

The choice of matrix type depends not only on the nature of the medical device being developed but also on various other factors such as organizational structures. A strong matrix type would work well...

Here is a SWOT analysis for the case mentioned above: Strength: The proposed lithium pump is a novel solution to the problem mentioned and the device could have a significant medical impact and impro...

Following the responses made above, ISO 14971 is an internationally recognized standard for risk assessment that both the US and EU use. ISO 13845 is a specific type of risk assessment standard that h...

Based on the question asked in the title, it is absolutely necessary for medical devices to have risk assessments. The risk assessment is conducted in accordance with international standards such as t...

The purpose of design control is to create a structured method of managing the design and development process of the product being made. There are several ways design control can be conducted. Design ...

A project proposal should include an executive summary, where a brief overview of the project is discussed. It should also include the business needs for the project as well as the objectives of the p...

When it comes to significant errors found in design input documents (DID) or design specification documents (DSD), several steps are often taken to rectify the error. First, the error must be identifi...