Prior to this lecture I had never learned about the AdvaMed Code of Ethics. For those unfamiliar with the topic, the AdvaMed Code of Ethics outlines guidelines on what is considered ethical interactio...

A non-disclosure agreement (NDA) is a legally enforceable agreement between individuals or parties that ensures information which will be discussed or shared remains confidential. Therefore, an NDA is...

As per the responses from my peers, all businesses require contracts. As per this weeks lecture, contracts must demonstrate the capacity and intention for legal relations, include an offer and accepta...

Organizational culture is a system of shared values, norms, and beliefs that are internally and externally promoted. An organization's culture typically attracts talent who are like-minded and have a ...

I believe a successful project team must have a diverse set of skills and experiences in order to complement one another in areas that ones' peers may be lacking. However, I believe it is more importa...

As per the PMBOK Guide, there are eight types of organizational structures seen when running a business: organic, functional, multi-divisional, matrix (strong/weak/balanced), project-based, virtual, h...

We learned this week that often times the people who make up the risk management team are also on the project team. When/why would this not be ideal?

Hi everyone! In this weeks lecture material, Dr. Simon shared a document which outlines risk analysis instructions. In this document he breaks down processes that require risk analysis: Product Reali...

Post-market surveillance is the practice of monitoring medical devices as well as taking reactive and proactive actions once the equipment is sold and in the market to ensure compliance with regulator...

As someone who works primarily on post-market surveillance of medical imaging equipment, it is my responsibility to determine the root cause when a system is not functioning properly. Imaging is commo...

I believe only conducting verification and validation studies is acceptable for a class I medical device or a class II medical device that is substantially equivalent to an existing product and requir...

It is important to note that design controls are just a singular subpart that are reviewed to ensure compliance with quality system regulations. Design controls provide a formalized approach to design...

As per the responses from most of my peers, without clear design controls the project timeline will continuously have to be modified and updated as new design inputs reveal themselves or a scope chang...

Upon reading through responses from my peers, this seems like really fun thread to respond to. Another example of a medical device with important design specifications include drug eluting stents. Som...

As we discussed, there are nine design controls listed in 21 CFR 820.30 which include planning, input, output, review, verification, validation, transfer, design changes, and the design history file. ...