A medical company of that size and revenue should exist as in incorporation vs an LLC. Some of the benefits of owning and incorporation over an LLC include the following. Corporation owners enjoy limited liability protection, and are usually not individually responsible for business debts. Also they often gain tax gains, such as writing off…[Read more]

Walmart
Return on Equity:
Return on equity expresses net income as a percentage of shareholders equity. ROE values about 9-10% are considered strong and ROE above 25% is considered excellent. Walmart has an ROE of 17.5
Debt to equity ratio: Total debt/total equity. If the value is high then it means the company is growing by borrowing money. For…[Read more]

Too much documentation: Many companies have too many documents that tend to hinder the function of QA/QC departments. Some major companies have excessive documentation that employees may become overwhelmed and possibly lose interest in the quality management system and therefore impede the expected outcome. A company that I worked for…[Read more]

One can always improve a department by defining processes – look at every aspect of production process and clearly define and streamline processes.
Always hire qualified candidates who possess the qualification, knowledge, skill and experience. Furthermore, always provide in house training to sharpen skill set and transfer knowledge form best e…[Read more]

The only way one should see this as a burden is if they have no idea of the consequences. Yes, QA/QC might cause you to rework, may cause delays, re-designs, failure analysis, retesting, downtime and lack of flexibility but imagine losing everything due to a simple error that could have been prevented during QC/QA. What if this error was due to…[Read more]

De novo classification (513(f)(2) of the Federal Food, Drug, and cosmetic act) provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, bur for which there is no legally marketed predicate device.…[Read more]

It falls under combination products per the definitions below:
Combination products are products that combine drugs, devices and or biological products.
1. A product comprised of two or more regulated components
2. Two or more separate products packaged together in a single package
3. A drug, device, or biological product packaged separately…[Read more]

The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the tobacco control act. The purpose of regulating tobacco products is to use the best available science to…[Read more]

The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the tobacco control act. The purpose of regulating tobacco products is to use the best available science to…[Read more]

Even though research for both generations are important, I would rather work on research for the present generation. My goal is to help and provide solution for problems that are currently at hand. Just imagine being able to cure a child and seeing the joy on their faces. I believe that would be the best reward one may ask for. Currently…[Read more]

The pitfall to awarding the trial to this university could bring about ethical issues. With so many ties to the university one could assume possible manipulation of data to favor the clinical trial. Also, the risk of kickbacks associated with awarding the contract to alma mater.
Depending on the location of this lab the preclinical trials may…[Read more]

Various tests need to determine the safety of the product before use in clinical studies (21 CFR 312.23(a)(8)). A complete description of material composition should be made available, detailed specification for formulation and chemical composition. The preclinical data is usually derived from animal studies. The test chosen should be geared…[Read more]

Missing a milestone may not be a failure if one meets the agreed deadline set in communication with a client. Milestones are put in place to ensure key deliverables are achieved according to the timelines set by the project manager. It is a measuring stick used to show forward movement and progress. I have been in many projects and when the…[Read more]

A portfolio is a view of all programs or projects that a company has in its pipeline to meet business objectives. Portfolio strategy involves the path the investors can take to use the company’s assets to attain financial goals while project portfolio takes into account all projects and programs managed together to achieve an o…[Read more]

Challenges that project managers for medical devices face differ from those that construction project managers face in a few ways. Construction project managers and medical device mangers both have to ensure the project is on track and according to plan. They both manage the project so it is completed on time and within budget. For construction…[Read more]