My company utilizes FMEA while the planning phase to assess risk. As mentioned in the lecture, FMEA is Failure Mode Effects Analysis. This systematic approach allows primarily those within the healthc...

To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that ...

In the company I work for, I've seen several user requirements documents as well as risk analysis forms which include user requirements embedded with defined risk levels. User requirements documents h...

Working in industry I've had the chance to utilize gaant charts to structure a project which is focused around transitioning our documents to the latest ISO 13485:2016 standard before audits this mont...

Design review meetings are essential to ensure that the design adheres to both each stage of the Product Development Process as well as provide feedback per each stage. One of the design meetings I we...

To add to the discussion I believe that a complete Design Control System maintains the established feedback loop where the product is documented adequately while providing room for improvement along t...

To add to the discussion, meeting minutes allows the team to ensure that every action is accounted for. Also a missing member can be brought up to speed with the meeting minutes and then briefly suppl...

When making a gantt chart, it is crucial to have met certain criteria. In my current job, I had to develop a gaant chart in order to facilitate a steady transition of ISO 13485:2003 to 2016. There the...

A mission statement describes the company's reason as to why they exist. This differs from the vision statement where the company states what the future successful state of the company would be. These...

Emotional Intelligence primarily focuses on how an individual is able to identify, consider and control their internal emotions as well as identify these in others. This involves various aspects of se...

The company that I chose to focus on is Stryker Corporation. Stryker is best known for their development of orthopedic products and implants, patient handling and emergency medical equipment, to name ...

Main difference between a public and private company is that a public company sells a part of its business to the public through public offerings. A private company is owned by a handful of people. Th...

A sole proprietor owns the entire business assets as personal property, as mentioned above. With that being said, it is possible to transfer the company to another person. The sole proprietor is allow...

Personally, I have thought about the possibility of a start-up company but within the biologics/pharmaceutical side. With that being said, I would prefer to create an LLC business. With a Limited Liab...

Ways to abide to procedure for all departments can be to collaboratively implement a procedure which all voices partake in the creation of such procedure. That way, upper management involved can hear ...