Another method used is Expected Damage-Cost Analysis (EDCA). This method evaluates how often different hazards occur and ultimately estimates the damage cost per year. Results also include suggestions...

At my company, we document user requirements in its own document. The user requirements also drive design input requirement and are linked via a trace. When an input requirement is changed or modified...

From a professionalism stand point, I think the gantt chart and team expectations are important, but I believe the risk management deliverables and the combined effort to identify input requirements. ...

I work for a company that manufactures handheld blood analyzers. In addition to the verifications performed to ensure the device reads samples within given limits. There are some general functionality...

In my experience, Supplier notification for custom components is extremely important for companies that outsource some of their components. At my company, it is required to send the supplier a notific...

I currently work in the industry but I’ve had little experience creating and managing Gantt charts. One issue that I face EVERY TIME I make a chart is adding too much detail. Because I know so much ab...

Of course in the medical device industry they say “if its not documented, it didn’t happen.” So capturing decisions made and the logic behind the scope of the discussion is always valuable. In my pers...

Similar to some posts above, I would also like to be an investigator. It seems like they are directly involved in the meat a potatoes of the trail. But I also think the IRB role is interesting as well...

According to Johns Hopkins, in the 1950’s the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic medical centers. But the Nuremberg Code was in pl...

I agree with the posts above that placebo trials are needed. However, the experiment design must be controlled in a way such that ethical concerns are mitigated. Ethical concerns arise when a proven e...

According to LegalZoom, if the sons must create a new business since a sole proprietorship is non-transferable. Once the original sole proprietor dies and the business is transferred, all of the busin...

I read this article about how a company was ready to go public and I thought it was interesting. From what I understand going public must be a timely decision. Completing an IPO too early can have dis...

Abbott Laboratories reported revenues of $6.64 billion in 2Q17, exceeding the analysts’ estimates. Abbott stock gained more than 4% the day of its 2Q17 results release, on July 20, 2017. In 2Q17, Abbo...

Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporatin...

I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AAMI University. The trainings were hosted by FDA, c...