Almost all companies have an ethics/gift-giving policy in place. In these policies some of them allow you to take a client to a business dinner as long as it clearly business and not personal. These policies are in place to…   Read more»

This course provides valuable insight to what is expected in the medical device industry. As someone who has taken all of Dr. Simons courses I can honestly say these courses prepares you for almost every little situation, no matter department…   Read more»

“Despite popular belief, oral contracts are enforceable. They usually are not in your best interests, and end in a “he said, she said” battle. But as long as there is enough evidence, a court will enforce an oral agreement. However,…   Read more»

I think being able to recognize this for your employees is a skill that is absolutely necessary in the hiring process when considering someone for a management position. Your manager should be able to see where you as an employee…   Read more»

I agree organization does influence company culture to an extent. However, I do think work culture is a big part of retaining employees. You want your company to do well overall and employee satisfaction can be essential to their individual…   Read more»

Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most of you seem to prefer a Matrix structure. In my opinion a Matrix structure is great but it puts a lot…   Read more»

Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly relay the information required so that the intended user applies the device in its intended…   Read more»

I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our…   Read more»

In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation…   Read more»

The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and displaying the critical path of a project, however, they have their differences. In the simplest form…   Read more»

I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this is not always the case. At the company I am currently at we…   Read more»

Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what was discussed and reviewed during that meeting. In most companies there will be an SOP…   Read more»

Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yourself “Did I make this product correctly”. This means you are matching if the product meets…   Read more»

Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed safe and effective. Design controls are documented, objective evidence you establish throughout…   Read more»

“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union)…   Read more»